Clinical Trial Coordinator II

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for Clinical Trial Coordinator II

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

  

#LI-Remote

Responsibilities:

• Support the 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.
• 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.
• Ability to perform additional responsibilities as requested.

Qualifications:

• Bachelor’s degree preferably in Life Sciences, Nursing, Business Administration or related medical/scientific field, or minimum 1-3 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 preferred.
• 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.
• Ability to travel ~5%.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $92,000-$148,350

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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year. Holiday pay, including Floating Holidays – up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: -  https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on April, 16, 2026 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.

 

 

Required Skills:

 

 

Preferred Skills:

Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics