Agriculture, Food & Natural Resources

Clinical Research Coordinators

Plan, direct, or coordinate clinical research projects.

A Day In The Life

Agriculture, Food & Natural Resources Industry

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Salary Breakdown

Clinical Research Coordinators

Average

$133,350

ANNUAL

$64.11

HOURLY

Entry Level

$75,170

ANNUAL

$36.14

HOURLY

Mid Level

$113,630

ANNUAL

$54.63

HOURLY


Current Available & Projected Jobs

Clinical Research Coordinators

27

Current Available Jobs

880

Projected job openings through 2030


Sample Career Roadmap

Clinical Research Coordinators

Degree Recommendations


 Arizona Western College

 Central Arizona College

 Central Arizona College






Top Expected Tasks

Clinical Research Coordinators


Knowledge, Skills & Abilities

Clinical Research Coordinators

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

Customer and Personal Service

KNOWLEDGE

English Language

KNOWLEDGE

Administrative

KNOWLEDGE

Medicine and Dentistry

KNOWLEDGE

Administration and Management

SKILL

Active Listening

SKILL

Reading Comprehension

SKILL

Writing

SKILL

Coordination

SKILL

Speaking

ABILITY

Deductive Reasoning

ABILITY

Oral Comprehension

ABILITY

Oral Expression

ABILITY

Problem Sensitivity

ABILITY

Written Comprehension


Job Opportunities

Clinical Research Coordinators

  • Clinical Research Manager | General Medicine (Remote)
    Merck    Phoenix, AZ 85067
     Posted about 5 hours    

    **Job Description**

    This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

    The CRM could be responsible for a particular study for several countries in a cluster.

    **Responsibilities include, but are not limited to:**

    + Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).

    + Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

    + Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, c policies and procedures, quality standards and adverse event reporting requirements internally and externally.

    + Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.

    + Performs Quality control visits as required.

    + Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).

    + Responsible for creating and executing a local risk management plan for assigned studies.

    + Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

    + Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).

    + Identifies and shares best practices across clinical trials, countries, clusters.

    + Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.

    + Country POC for programmatically outsourced trials for assigned protocols.

    + As a customer-facing role, this position will build business relationships and represent our company with investigators.

    + Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).

    + Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.

    + Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with our Human Health Division as needed.

    **Extent of Travel** :

    + Up to 30% of working time

    **CORE Competency Expectations:**

    + Knowledge in Project Management and site management.

    + Strong organizational skills with demonstrated success required.

    + Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD.

    + Requires strong understanding of local regulatory environment.

    + Strong scientific and clinical research knowledge is required.

    + Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.

    + Experience functioning as a key link between Country Operations and Clinical Trial Teams.

    + Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.

    + Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.

    + Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.

    + Strategic thinking.

    + Ability to work efficiently in a remote and virtual environment.

    + Understand cultural diversity.

    + The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.

    **Behavioural Competency Expectations:**

    + Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO.

    + Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.

    + Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.

    + Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

    **Experience Requirements:**

    **Required** :

    + Minimum 5 years of experience in clinical research

    + CRA Experience preferred

    **Educational Requirements:**

    **Required** :

    + Bachelor degree in Science (or comparable)

    **Preferred** :

    + Advanced degree, (e.g., Master degree, MD, PhD

    **MRLGCTO**

    **\#EligibleforERP**

    **NOTICE** **FOR** **INTERNAL** **APPLICANTS**

    In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

    **Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

    EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

    EEOC GINA Supplement​

    Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

    Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

    **U.S. Hybrid Work Model**

    Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

    Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

    Expected salary range:

    $135,500.00 - $213,400.00

    Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    25%

    **Flexible Work Arrangements:**

    Remote

    **Shift:**

    Not Indicated

    **Valid Driving License:**

    No

    **Hazardous Material(s):**

    NA

    **Requisition ID:** R287876


    Employment Type

    Full Time

  • Lead Clinical Research Associate
    Actalent    Phoenix, AZ 85067
     Posted about 5 hours    

    Description:

    Lead CRA

    CRA oversight- tracking metrics of 5-7 CRAs

    Vendor Oversight

    Responsible for 2 sites independently as well as oversight

    Location: Mountain time

    The candidate will be primarily responsible for assisting the Clinical Operations team in the execution of clinical trial deliverables in an effective and efficient manner. The candidate will be responsible oversight of investigational sites in the United States. This includes: overall site management, and monitoring (including start-up, initiation, routine monitoring, and close-out visits), monitoring inventory of ancillary supplies, file maintenance, and ensuring recruitment goals are met.

    Requirements/Qualifications:

    - At least 3 years as a full-time Lead regional monitor working for a sponsor or Contract Research Organization (CRO)

    - Experience managing aspects of CRO functions is a plus

    - Travel is required for the position, this may be extensive at times

    - Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion

    - Extensive experience collaborating/interacting with counterparts at sponsor and other CROs/vendors (laboratories, drug depots, etc.)

    - Experience managing clinical trial investigational sites

    - Conducting site feasibility assessments, participating in or managing the site selection process, analyzing patient recruitment and retention rates

    - Organize and perform site initiation visits and site training activities

    - Perform periodic monitoring visits

    - Verify biological sample collection, storage, and shipping procedures at the site

    - Verify laboratory data is reviewed by the investigator, properly captured in the case report form, and if necessary, is being reconciled properly within the CRF

    - Organizing and monitoring investigator study files

    - Preparing and organizing local institutional review board(IRB)/ethics committee (EC) submissions in collaboration with the site(s) and Clinical Trials Associates

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    Diversity, Equity & Inclusion

    At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

    + Hiring diverse talent

    + Maintaining an inclusive environment through persistent self-reflection

    + Building a culture of care, engagement, and recognition with clear outcomes

    + Ensuring growth opportunities for our people

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.


    Employment Type

    Full Time

  • Lead Clinical Research Associate
    Actalent    Phoenix, AZ 85067
     Posted about 5 hours    

    Working with a small US based pharmaceutical company looking for an experienced Lead CRA! The ideal candidate will have existing experience serving as a lead and comfortable with regular travel. NASH experience is desired.

    Description:

    + CRA oversight- tracking metrics of 5-7 CRAs

    + Vendor Oversight

    + Responsible for 2 sites independently as well as oversight of additional

    Location: Mountain time

    The candidate will be primarily responsible for assisting the Clinical Operations team in the execution of clinical trial deliverables in an effective and efficient manner. The candidate will be responsible oversight of investigational sites in the United States. This includes: overall site management, and monitoring (including start-up, initiation, routine monitoring, and close-out visits), monitoring inventory of ancillary supplies, file maintenance, and ensuring recruitment goals are met.

    Requirements/Qualifications:

    - At least 3 years as a full-time Lead regional monitor working for a sponsor or Contract Research Organization (CRO)

    - Experience managing aspects of CRO functions is a plus

    - Travel is required for the position, this may be extensive at times

    - Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion

    - Extensive experience collaborating/interacting with counterparts at sponsor and other CROs/vendors (laboratories, drug depots, etc.)

    - Experience managing clinical trial investigational sites

    - Conducting site feasibility assessments, participating in or managing the site selection process, analyzing patient recruitment and retention rates

    - Organize and perform site initiation visits and site training activities

    - Perform periodic monitoring visits

    - Verify biological sample collection, storage, and shipping procedures at the site

    - Verify laboratory data is reviewed by the investigator, properly captured in the case report form, and if necessary, is being reconciled properly within the CRF

    - Organizing and monitoring investigator study files

    - Preparing and organizing local institutional review board(IRB)/ethics committee (EC) submissions in collaboration with the site(s) and Clinical Trials Associates

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    Diversity, Equity & Inclusion

    At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

    + Hiring diverse talent

    + Maintaining an inclusive environment through persistent self-reflection

    + Building a culture of care, engagement, and recognition with clear outcomes

    + Ensuring growth opportunities for our people

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.


    Employment Type

    Full Time

  • Sr Clinical Program Manager, Pharmacist - Remote
    Prime Therapeutics    Phoenix, AZ 85067
     Posted 1 day    

    Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make.

    **Job Posting Title**

    Sr Clinical Program Manager, Pharmacist - Remote

    **Job Description**

    + Leads the development of clinical program enhancements and better practices. Assists with development, enhancement, and maintenance of operational functions, policy and clinical support and provider education

    + Develops, implements, and monitors project plan requirements and timelines, ensures all necessary support, tools and technology are available, and follows up as needed. Meets with business process owners and other appropriate personnel to identify the project`s goals, objectives, critical success factors, and success measures.

    + Works closely with teams to ensure consistent delivery of approved programs to their client. Ensures operations are standardized at the fullest extent possible. Provides overall project coordination for the contract's clinical and operational functions.

    + Oversees and coordinates implementation of new specialty programs and serves as liaison between the company and customers as needed.

    + Assists in modifying implementation approaches within budget and operational framework.

    + Revenue Generation - Works jointly with Account Manager to ensure revenue goals, administrative expenses are managed.

    + Develops strong relationships with key contacts at client level.

    + Develops strong relationships and contacts within the company that are supportive of the achievement of increased revenue goals.

    + Supports other functions as requested throughout the program development lifecycle including finance, outcomes, communications and IT.

    + Communicates frequently, either by phone or in person, with client to report program progress, establish priorities and maintain positive client relationship. Responds to client`s requests for information. Assesses, investigates and resolves difficult issues to achieve customer satisfaction.

    + Responsible for oversight of all program reporting. Ensures standard and ad hoc reports are provided accurately and on time.

    **Minimum Qualifications:**

    + 2+ years of project/program management experience

    + 7+ years of clinical experience

    + Doctor of Pharmacy (PharmD) or Bachelor of Science Pharmacy Degree

    + Current pharmacist license in good standing with State Board of Pharmacy

    + Must be eligible to work in the United States without need for work visa or residency sponsorship

    **Additional Qualifications:**

    + Ability to work autonomously in a self-directed environment and function in environment of ambiguity

    + Superior ability to influence at all levels of an organization

    + Demonstrated application of strong market awareness and customer focus

    + Demonstrated ownership of complex, timely decisions

    + Proven ability to communicate technical and business information effectively to both technical and non-technical people

    + Superior ability to create and manage complex development projects in a highly dynamic environment

    + Demonstrated ability to pull together diverse teams to solve problems and pursue opportunities

    + Skilled at change management and leading change

    + Proficiency in office productivity software and tools (e.g. MS Word, Excel, PowerPoint etc)

    **Preferred Qualifications:**

    + PBM or PBM consulting experience

    + Managed care experience

    Potential pay for this position ranges from $109,480.00 - $186,120.00 based on experience and skills. Pay range may vary by 8% depending on applicant location.

    To review our Benefits, Incentives and Additional Compensation, visit our Benefits Page (https://www.primetherapeutics.com/careers/benefits/) and click on the "Benefits at a glance" button for more detail.

    _Prime Therapeutics LLC is an Equal Opportunity Employer. We encourage diverse candidates to apply and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, genetic information, marital status, family status, national origin, age, disability, veteran status, or any other legally protected class under federal, state, or local law._

    Positions will be posted for a minimum of five consecutive workdays.

    Prime Therapeutics' fast-paced and dynamic work environment is ideal for proactively addressing the constant changes in today's health care industry. Our employees are involved, empowered, and rewarded for their achievements. We value new ideas and work collaboratively to provide the highest quality of care and service to our members.

    If you are looking to advance your career within a growing, team-oriented, award-winning company, apply to Prime Therapeutics today and start making a difference in people's lives.

    Prime Therapeutics LLC is an Equal Opportunity Employer. We encourage diverse candidates to apply and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. **​** If you are an applicant with a disability and need a reasonable accommodation for any part of the employment process, please contact Human Resources at 1.866.469.1257 or email [email protected].


    Employment Type

    Full Time

  • Clinical Research Coordinator I
    HonorHealth     SCOTTSDALE, AZ 85258
     Posted 1 day    

    Overview Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let’s go beyond expectations and transform healthcare together. HonorHealth is one of Arizona’s largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 14,000 team members, 3,700 affiliated providers and hundreds of volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary Position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute. The position works closely with all Research Staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices. Provides data management project support for multidisciplinary clinical research, including patient screening for study eligibility, obtaining informed consent and subject registration. Collects, verifies, organizes and records clinical information and data in case report forms. Abstracts data from necessary sources to complete all forms to the required quality. Performs the following data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Assists in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Assists with subject follow-up for clinical protocols. Works with the Research Staff to assist with the tracking of study progress and development of periodic status reports. Assist with preparation of annual reports and statistical information on clinical research as required by Institute, System, IRB or investigators. Obtains all reports and submits data forms and pathology materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database to the Research Staff. Provides assistance as needed to peers to ensure that study deadlines are met. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing. Maintains communication with the Research Staff regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements. Assists the Research Staff with the coordination and completion of submission packets for the IRB. Maintains working relationships with external customers (e.g. professional research organizations and physicians) to facilitate the submission of clinical investigational material to the appropriate regulating body. Performs other related duties as assigned. Qualifications Education High School Diploma or GED Required Experience 2 years experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program Required


    Industry

    Health Sciences

    Employment Type

    Full Time

  • Senior Clinical Research Associate- Florida (REMOTE)
    Merck    Phoenix, AZ 85067
     Posted 2 days    

    **Job Description**

    The role is accountable for performance and compliance for assigned protocols and sites in a country.

    Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

    Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

    Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

    **Responsibilities include, but are not limited to:**

    + Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

    + Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

    + Gains an in-depth understanding of the study protocol and related procedures.

    + Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

    + Participates & provides inputs on site selection and validation activities.

    + Performs remote and on-site monitoring & oversight activities using various tools to ensure:

    + Data generated at site are complete, accurate and unbiased.

    + Subjects’ right, safety and well-being are protected.

    + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

    + Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

    + Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

    + Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.

    + Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.

    + Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

    + Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

    + Supports and/or leads audit/inspection activities as needed.

    + Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

    + Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

    + Could perform Quality control visits if delegated by other roles and trained appropriately.

    **Extent of Travel**

    + Ability to travel domestically and internationally approximately 65%-75% of working time.

    + Expected travelling ~2-3 days/week.

    + Current driver’s license preferred (Must have in certain countries).

    **Qualifications, Skills & Experience**

    **CORE Competency Expectations:**

    + Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

    + Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

    + Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

    + Demonstrated ability to mentor/lead.

    + Hands on knowledge of Good Documentation Practices.

    + Proven Skills in Site Management including independent management of site performance and patient recruitment.

    + Demonstrated high level of monitoring skill with independent professional judgment.

    + Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

    + Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.

    + Experience with conducting site motivational visit designed to boost site enrollment.

    + Capable of managing complex issues, works in a solution-oriented manner.

    + Performs root cause analysis and implements preventative and corrective action.

    + Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.

    **Behavioral Competency Expectations:**

    + Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.

    + Able to work highly independently across multiple protocols, sites and therapy areas.

    + High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

    + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

    + Demonstrates commitment to Customer focus.

    + Works with high quality and compliance mind-set.

    + Positive mindset, growth mindset, capable of working independently and being self-driven.

    + Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

    **Experience Requirements:**

    **Required:**

    + Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.

    **Preferred:**

    + B.A./B.S. with strong emphasis in science and/or biology

    MRLGCTO

    \#EligibleforERP

    **NOTICE** **FOR** **INTERNAL** **APPLICANTS**

    In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

    **Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

    EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

    EEOC GINA Supplement​

    Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

    Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

    **U.S. Hybrid Work Model**

    Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

    Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

    Expected salary range:

    $122,800.00 - $193,300.00

    Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    50%

    **Flexible Work Arrangements:**

    Remote

    **Shift:**

    Not Indicated

    **Valid Driving License:**

    Yes

    **Hazardous Material(s):**

    NA

    **Requisition ID:** R287413


    Employment Type

    Full Time

  • Senior Clinical Trial Coordinator
    J&J Family of Companies    Phoenix, AZ 85067
     Posted 2 days    

    Senior Clinical Trial Coordinator - 2406177877W

    **Description**

    Abiomed, part of Johnson & Johnson's MedTech is recruiting for a Senior Clinical Trial Coordinator II, located in Danvers, MA or Remote. _Remote work options may be considered on a case-by-case basis and if approved by the Company._

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

    The Senior Clinical Trial Coordinator (Sr. CTC) supports the planning and coordination in all aspects of clinical trial operations. This position requires a thorough understanding of clinical trials, including how to support a trial from site feasibility/qualification to site activation. A Sr. CTC will work closely with the clinical project team to collect all essential regulatory documents for a clinical study (at both study and site level) in a timely fashion and store appropriately while ensuring compliance with ICH/GCP guidelines, federal regulations, and corporate policies and procedures. The position involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.

    **Key Responsibilities:**

    + Take a lead role in management of trial-related systems such as the electronic Trial Master File (eTMF), including set up, maintenance and study close out.

    + Assures collection of essential clinical trial documents (i.e., CVs, Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements) from investigational sites for efficient study start-up/site activation.

    + Support site start-up activities including reviewing study specific ICF templates, managing and communicating the status of sites and study’s start-up progress.

    + Plan, coordinate, and arrange study communications on and off-site with both internal and external partners.

    + Responsible for supporting the drafting of meeting agendas and detailed meeting minutes.

    + Maintain quality of collected regulatory documents, which include a precise QC process and proper review in accordance with Good Documentation Practices (GDP) when documents are received.

    + Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions and other trial-related information.

    + Collaborate with multifunctional teams to resolve issues on collected essential documents as required per assigned studies.

    + Maintain accuracy of clinical trial registration information.

    + Provide assistance with communication and coordination for trial committee interactions, as needed.

    + Provide support during audits and inspections, as applicable.

    + Create, populate, review, approve, distribute, and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager.

    + Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation.

    + Actively participate and contribute ideas in the development of department initiatives and goals that will make a difference in the efficiency and effectiveness of clinical operations.

    + Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs.

    + Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations.

    + Mentor and coach junior-level employees and support the efforts of onboarding new hires.

    + Ability to perform additional responsibilities as requested

    **Qualifications**

    **Education:**

    + Bachelor’s degree required preferably in Life Sciences, Nursing, Business Administration or related medical/scientific field

    **Required:**

    + Minimum 3-5 years relevant clinical research experience working at an Investigator Site, Sponsor or CRO

    + Knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements.

    + Experience working with eTMFs and CTMS.

    + Must be computer savvy and highly proficient in Microsoft Office: Word, PowerPoint, and Excel (i.e., format documents, presentations, spreadsheet formulas).

    + Able to work and thrive in a fast-paced team environment across cross-functional teams.

    + Highly organized, excellent prioritization, self-motivated, and detail oriented.

    + Demonstrate excellent communication, verbal and written, and interpersonal skills.

    **Other:**

    + Industry experience (Cardiovascular, Medical Device, Pharmaceutical, Biotech and/or CRO industries)

    + Experience creating Clinical Trial Communications (newsletters, etc.), detailed PowerPoint presentations strongly preferred.

    + Ability to travel <10%.

    **This job posting is anticipated to close on 4.9.2024. The Company may however extend this time-period, in which case the posting will remain available on** **https://www.careers.jnj.com** **to accept additional applications.**

    For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $90,000 to $125,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

    **Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.**

    **Primary Location** NA-US-4887-Danvers

    **Other Locations** NA-United States

    **Organization** ABIOMED Inc.(6942)

    **Job Function** Clinical Trial Support

    **Req ID:** 2406177877W


    Employment Type

    Full Time

  • Clinical Research Coordinator
    Phoenix Children's Hospital     Phoenix, AZ 85016
     Posted 3 days    

    This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.


    Industry

    Health Sciences

    Employment Type

    Full Time

  • Clinical Research Coordinator
    Phoenix Children's Hospital     Phoenix, AZ 85016
     Posted 3 days    

    This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.


    Industry

    Health Sciences

    Employment Type

    Full Time

  • Clinical Research Coordinator-Early Cancer Therapeutic
    Mayo Clinic    Phoenix, AZ 85067
     Posted 4 days    

    **Why Mayo Clinic**

    Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans (https://jobs.mayoclinic.org/benefits/) – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.

    **Responsibilities**

    Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Gives direction to and works cooperatively with other research staff. Collaborates with various departments within the institution. Works cooperatively with other investigators and personnel at all levels. Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.

    Position Overview: (Major Functions and Non-Essential Functions):

    Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborates with research team to assess feasibility and management of research protocols. Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Provides education/training for others within the department. Performs administrative and regulatory duties related to the study as appropriate. Some travel may be required. ADDENDUM (if applicable) Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participates in other protocol development activities and executes other assignments as warranted and assigned.

    **Qualifications**

    Minimum Education and/or Experience Required: (Education Requirements and Experience):

    HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Experience should be in the clinical setting or related experience.

    Additional Experience and/or Qualifications: (Has Achieved Competency in the Following Areas, Job Knowledge and Additional Considerations):

    Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.

    Licensure/Certification Required:

    N/A

    **Exemption Status**

    Nonexempt

    **Compensation Detail**

    $30.12 - $45.19

    **Benefits Eligible**

    Yes

    **Schedule**

    Full Time

    **Hours/Pay Period**

    80

    **Schedule Details**

    Monday-Friday (8am-5pm)

    **Weekend Schedule**

    N/A

    **International Assignment**

    No

    **Site Description**

    Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. (https://jobs.mayoclinic.org/alllocations)

    **Affirmative Action and Equal Opportunity Employer**

    As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

    **Recruiter**

    Matt Burdick

    **Equal opportunity**

    As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.


    Employment Type

    Full Time


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