Clinical Trial Coordinator II

Johnson & Johnson Innovative Medicine • Danvers, MA

1d • $92,000 - $148,350 • Remote

About The Position

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. 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

Requirements

• 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.
• 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%.

Nice To Haves

• Experience working with eTMFs and CTMS preferred.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level