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