Statistical Assistants

Job Title : Research Associate III

Location : Tucson, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support company projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities

• Designs a wide range of experimental protocols.

• Executes bench experiments; makes detailed and general observations and analyzes data.

• Prepares technical reports, summaries and quantitative analyses.

• Maintains complete and accurate records.

• Normally receives general directions on routine and new assignments.

• Identifies and implements improvements to work processes and laboratory environment.

• Recognized expert for area of expertise.

• Recognizes and documents activities for publication and/or patent potential.

• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for

obtaining results.

• Participates in cross functional technical teams such as a failure investigation or core team.

• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and

providing input to project planning.

• Establishes interfaces across other organizational groups.

• Trains others in areas of expertise.

• Troubleshoots problems and institutes corrective action.

• Prepares and presents experimental procedures and results in group and project teams.

• Monitors work to ensure quality, and continuously promote Quality First Time.

• Other duties as assigned by management.

Requirements

Education/Experience:

• Bachelor’s Degree in Science required

• 4 years relevant job experience required

Knowledge, Skill or Ability:

• Knows wide range of experimental techniques and skilled in their applications.

• Capable with searching scientific literature to gain general and specific information.

• Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Title : Research Associate II

Location : Tucson, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

This is a role in Stability & Surveillance (S&S) in Oncology Assay Development (OAD) organization. The team is responsible for real-time stability testing to support expiration dating of company reagents, as packaged under recommended storage conditions, to ensure that label claims are met throughout a product’s shelf life. The stability team members work closely across various Pathology Customer Area (RTD) functions, including Tissue procurement & Histology (BAM), Medical Office, Development, Lifecycle, Investigation & Resolution, Manufacturing, Quality, Regulatory, and Global Organizations.

This individual will primarily perform the supporting (Tissue Qualification) activities necessary for monitoring of the commercial products as packaged under recommended storage conditions over a period. Activities may include tissue qualification & block search process; stability testing to confirm that products meet specifications; data management; participating in evaluating and reporting results; generating required documentation/procedures/technical reports in support of daily activities. Additional tasks/projects may be assigned based on team needs. This individual will mainly interact with internal stability team members, Pathology/ Medical office, and Tissue (Bio-specimen) Management; interactions with other cross-functional groups will be dependent on special circumstances or assignments.

Requirements

Education/Experience:

• Bachelor’s Degree in Science required

• Degree in Biology, Biochemistry, Chemistry , Molecular Biology, Microbiology preferred

• 2 years of relevant job experience required

• Background in immunohistochemistry, histology/pathology, pharmaceutical chemistry, analytical chemistry, biology, biochemistry, or biomedical engineering preferred

Knowledge, Skill or Ability:

• Laboratory experience, familiarity (hands-on experience) with laboratory techniques is strongly preferred (pipetting, making dilutions )

• Ability to follow Quality System regulations, including Design Control, Stability protocols, Scientific study design

• Ability to work independently, independent thought process and take directions well

• GDP (Good Documentation Practice), Good record-keeping, and GLP (Good Lab Practice)

• Must have the ability to adhere to design control procedures in compliance with FDA and ISO guidelines

• Good organization skills, Good Communication skills, Time Management skills, Attention to details required

• Skilled at using Microsoft Word, power-point and Excel

• Good Technical writing (writing protocols and reports) and Oral presentation skills preferred

• Experience from the medical device and/or pharmaceutical industries is preferred

• Project management experience is preferred

• Quality Control background is preferred

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Title : Research Associate I

Location : Tucson, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support company projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities

• Executes laboratory experiments; makes detailed observations and analyzes data.

• Prepares technical reports, summaries and quantitative analyses.

• Maintains complete and accurate records.

• Normally receives detailed directions on all work.

• Makes suggestions to improve work processes.

• Assists in reducing to practice patentable inventions.

• Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors.

• Exercises judgment within defined procedures and practices to determine appropriate action.

• May participate in cross functional technical team activities.

• Presents and discusses data within group.

• Monitors work to ensure quality, and continuously promote Quality First Time.

• Other duties as assigned by management.

Requirements

Education/Experience:

• Bachelor’s Degree in Science required

• Entry Level – less than 1 year experience

Knowledge, Skill or Ability:

• Knows basic and some specialized laboratory techniques.

• Familiar with searching scientific literature.

• Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Title : Senior Research Associate

Location : Tucson, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support company projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities

• Designs experimental plan to support project objectives.

• Executes bench experiments; makes detailed and general observations and analyzes data.

• Prepares technical reports, summaries and quantitative analyses.

• Maintains complete and accurate records.

• Normally acts independently for developing methods, techniques and evaluation criteria for obtaining results.

• Identifies and implements improvements to work processes and laboratory environment.

• Recognized expert across a wide range of techniques and their application.

• Recognizes and documents activities for publication and/or patent potential.

• May participate in scientific conferences and contribute to scientific journals.

• Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.

• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

• Participates or leads cross functional technical teams such as a failure investigation or core team.

• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.

• Establishes interfaces across other organizational groups.

• Trains others in areas of expertise.

• May supervise lower level personnel and laboratory operations.

• Troubleshoots problems and institutes corrective action.

• Prepares and presents experimental procedures and results in group and project teams.

• Monitors work to ensure quality, and continuously promote Quality First Time.

• Other duties as assigned by management.

Requirements

Education/Experience:

• Bachelor’s Degree in Science Required – Master’s degree preferred.

• 6 years or more relevant experience with a Bachelor’s Degree required – or less than 1 year or more relevant experience with a Master’s Degree.

Knowledge, Skill or Ability:

• Knows a wide range of experimental techniques and is skilled in their applications.

• Acts independently to determine methods and procedures on new assignments.

• Capable of searching scientific literature to gain general and specific information.

• Skilled with use of word processing, spreadsheets, graphical and presentation.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Summary The PPGRU's mission is to increase the productivity, profitability and sustainability of agriculture in arid environments by developing new germplasm for both traditional and alternative crops and by improving plant responses to abiotic stresses and to changes in the global environment. Emphasis is placed on oilseeds crops used for food, and biofuels, and establish new industrial and bioenergy crops for semi-arid regions. **ANNOUNCEMENT IS OPEN UNTIL FILLED OR FEBRUARY 5, 2025** Responsibilities Provide technical and professional guidance to develop and implement novel molecular biology and genomic solutions to improve industrial oil crops.. Conduct research, in collaboration with other ARS scientists and with academic and private industry scientists, as needed. Develop improved plant populations including double haploid (DH) populations and carry out activities including nursery design, planting, crossing, phenotypic characterization and sample collection for DNA marker activities. Establish a double haploid (DH) protocols, including culture media preparation, plating anthers, transfer callus and plantlets in various growth chambers and greenhouses. Lead establishment of processes and practices related to industrial crops molecular breeding methodologies including developing DNA markers for marker-assisted selection (MAS) and genomic selection (GS). Support the applications of genomic and transcriptomic tools in breeding programs. Implement, interpret, report and present results from laboratory, greenhouse, and field studies. Requirements Conditions of Employment Qualifications This position requires a Ph.D in the plant sciences, plant genetics, plant breeding or related fields or a related field of study that has equipped the applicant with the necessary knowledge, skills and abilities to perform the duties and responsibilities of the position. Applicants must meet basic Office of Personnel Management (OPM) Qualification Standard's requirements of the scientific discipline necessary to perform the duties and responsibilities of the position. 0401 Series - General Natural Resources Management and Biological Sciences Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. Or Combination of education and experience: Courses equivalent to a major, as shown in above, plus appropriate experience or additional education. 0440 Series - Genetics Degree: genetics; or one of the basic biological sciences that included at least 9 semester hours in genetics. Graduate Education: Genetics, or a curriculum or pattern of training that placed major emphasis on genetics. Graduate study in related fields such as agronomy, horticulture, animal, dairy, or poultry husbandry, entomology, microbiology, plant pathology, chemistry, molecular and cellular biology, and physiology that involved cross-training in genetics is qualifying, provided it placed sufficient emphasis on genetics. Evaluation of Education: Most students in the field take graduate work because specific training in genetics may be limited at the undergraduate level. Under these circumstances, it may be necessary to evaluate undergraduate course work in genetics in one of two ways, as described below, to determine whether or not it is qualifying. Courses dealing with genetics, some phase of genetics, or specific techniques that are applied in genetics work are acceptable. This includes courses in genetics, plant or animal genetics, molecular and cellular biology, mathematics and statistics (as they apply to genetics), population dynamics, and certain techniques such as those dealing with irradiation. Course work consisting of an appropriate combination of basic courses in genetics and cytology or statistics are also acceptable. In Addition to the Qualification Requirements outlined above, the incumbent will require the education and experience outlined below. A PhD in the molecular plant sciences, plant genetics, plant breeding or related fields. Working knowledge of current methods used in plant biology, including techniques used in plant genetics and genomics and tissue cultures techniques such as anther and microspore cultures are required. Ability to develop new molecular markers. Knowledge of QTL/candidate gene discovery for genes controlling abiotic stresses using transcriptome analysis and QTL/gene mapping are desired. Education This position has a positive education requirement. You must submit a copy of your academic transcripts OR a list of college courses with credit hours, dates completed, and grades received to verify education when applying for this position. If this information is not provided, your education may not be appropriately evaluated and you may lose consideration for this position. If you are selected for this position, you will have to provide an official copy of your transcripts prior to entering on duty. Application materials will not be returned. Additional Information Recruitment or Relocation Incentive may be authorized. Final determination to pay an incentive will be made by the hiring official at time of job offer. This position may be eligible to telework up to four days per week, based upon the duties of the position. This position may also be eligible for flexible work arrangements as determined by agency policy and any applicable collective bargaining agreements. Privacy Act Statement - FBI 3.2.4.2. Noncriminal Justice Applicant's Privacy Rights: https://www.fbi.gov/services/cjis/compact-council/guiding-principles-agency-privacy-requirements-for-noncriminal-justice-applicants or Agency Privacy Requirements for Noncriminal Justice Applicants - FBI

**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, company 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.

**Educational Requirements:**

**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 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:

$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:** R290271

Clinical Research Associate II - 2406181956W

**Description**

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Clinical Research Associate II. 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/.

Reporting to the Manager, Clinical Research Associates, the person in this role is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team. This person will be fully engaged, and we guarantee there will never be a dull moment. Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.

**Key Responsibilities:**

+ Perform study start-up activities including ICF review, create study-specific essential document lists, manage and communicate the status of study progress and activities

+ Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge; develop processes to mitigate reoccurrence throughout study phases

+ Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations

+ Assess current processes, find opportunities and propose solutions to improve efficiencies within and across related functional areas

+ Partner with cross-functional teams (e.g., clinical data management, medical teams) to assist with query management, data reviews, and task resolution

+ Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation

+ Conduct site monitoring visits and follow-up to identify significant issues and ensure that all clinical aspects of studies are being carried out in accordance with study requirements

+ Assess all data documentation, reports, records, transcripts, exam results, etc. for consistency with case report forms as well as monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.

+ Maintain oversight of and provide insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); communicate findings to principal investigators and site staff as well as study sponsor management and leadership staff

+ Maintain appropriate regulatory documentation both internally and externally by ensuring site has the required regulatory documents to conduct the trial/study and that source documentation is properly recorded.

+ Perform investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.

+ Develop and deliver trainings on GCPs, protocols, amendments, database, compliance, device accountability, adverse event reporting, regulatory documentation requirements

+ Train and proctor new employees on trial and study-related activities

+ Contribute to the development of clinical protocols, informed consent forms, and case report forms, as requested.

+ Edit/amend informed consent documents

**Qualifications**

**Education:**

+ Bachelor's Degree in a related Science field

**Required:**

+ 3 years of field monitoring experience

+ Experience working in medical device industry

+ Excellent written and verbal communication, presentation, interpersonal, and analytical skills

+ Proven problem-solving and critical thinking skills

+ Demonstrated expertise in MS Office Suite, including Word, Excel, Adobe

+ Ability to travel up to 65%

**Preferred:**

+ Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification)

**This job posting is anticipated to close on 4.18.2024. 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 $88,000 to $123,000. 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 Project Management

**Req ID:** 2406181956W

Summary This is a Direct Hire Authority (DHA) solicitation utilizing the DHA for Certain Personnel of the DoD Workforce to recruit and appoint qualified candidates to positions in the competitive service. About the Position: The Position is with the Futures and Concepts Center, G-3/5/7 Analysis Division Fort Huachuca, AZ duty station. The incumbent will serve as an Operations Research Analyst providing cost benefit analysis. Responsibilities Serve as a senior operations analyst with a focus on cost benefit analysis and technical authority for the interpretation and presentation of analytical findings and conclusions. Perform a broad range of cost-benefit studies in areas relating to Doctrine, Organization, Training, Materiel, Leader, Personnel, and Facility (DOTMLPF) requirements within the Department of Defense (DoD) and Army. Independently plans and accomplishes special studies/staff actions. Keep abreast of advances in state-of-the-art technology and new methods by means of membership in professional organizations, attendance at professional conferences, and consultation with other analysts in the cost and benefit analysis community. Requirements Conditions of Employment Qualifications Who May Apply: US Citizens In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document. Basic Requirement for Operations Research Analyst (1515): Degree: Bachelor's degree (or higher degree) in operations research; or a degree with at least 24 semester hours in a combination of operations research, mathematics, probability, statistics, mathematical logic, science, or subject-matter courses requiring substantial competence in college-level mathematics or statistics. At least 3 of the 24 semester hours must have been in calculus. In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below: One year of specialized experience which includes which includes: 1) Applying advanced operations research, mathematics, and statistics sufficient to perform cost benefits analysis; 2) Applying knowledge of economic analyses and other cost analyses methods, models and tools, to integrate cost and benefit analyses; and 3) Leading and organizing studies of complex issues and problems to effectively plan, prepare, and support a range of economic analyses. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (GS-12). You will be evaluated on the basis of your level of competency in the following areas: Education ***NOTE: TRANSCRIPTS ARE REQUIRED even if you are a current federal employee.*** FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications Additional Information Male applicants born after December 31, 1959, must complete a Pre-Employment Certification Statement for Selective Service Registration. You will be required to provide proof of U.S. Citizenship. One year trial/probationary period may be required. Direct Deposit of Pay is required. Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees. If you have retired from federal service and you are interested in employment as a reemployed annuitant, see the information in the Reemployed Annuitant information sheet. This is a(n) 36 Career Field position. Multiple positions may be filled from this announcement. Salary includes applicable locality pay or Local Market Supplement. When you perform a Civilian Permanent Change of Station (PCS) with the government, the Internal Revenue Service (IRS) considers the majority of your entitlements to be taxable. Visit https://www.dfas.mil/civilianemployees/civrelo/Civilian-Moving-Expenses-Tax-Deduction/ for more information. Permanent Change of Station (PCS) allowances MAY be authorized, subject to the provisions of the Joint Travel Regulations and an agency determination that a PCS move is in the Government Interest. The following special programs/incentives MAY be offered if it is appropriate to the position being filled and in the best interest of the government: Advanced in Hire, Advanced Leave Accrual, Recruitment or Relocation Incentives. (If offered, a signed Service Agreement will be required.)

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.

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.