Senior Clinical Research Associate

Senior Clinical Research Associate – Cardiovascular Location: Danvers, Massachusetts, United States of America Job Category: Professional – R&D Operations – Clinical Trial Project Management This field‑based role is responsible for overseeing the planning, execution, and monitoring of cardiovascular clinical trials, ensuring compliance with protocols, GCP, and regulatory requirements. Responsibilities Coordinate study start‑up and conduct activities, including drafting study‑specific templates and plans, developing essential document lists, and communicating study progress status. Contribute to the development and revision of clinical protocols, informed consent forms, and case report forms. Review, edit, amend, and approve site‑level informed consent documents. Partner with cross‑functional teams (clinical data management, medical safety, etc.) to manage queries and data entry/submission. Assist project management team with monitoring visit review, study metric review, and training activities. Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation, and mentor new employees. Conduct site initiation visits and train site personnel on sponsor and regulatory requirements. Conduct site monitoring visits, follow‑up on significant problems, and ensure clinical aspects align with protocols and GCPs. Verify trial/study data, maintain regulatory documents, and ensure source documentation is properly recorded. Assess data documentation for consistency with case report forms and monitor trial safety in line with protocols, GCP, PHI, and regulatory requirements. Validate investigational device accountability and track device disposition. Provide oversight and insight into trial activities (e.g., protocol non‑compliance trends, enrollment, data quality) to clinical sites and study management staff. Investigate discrepancies in study documentation and implement corrective and preventative actions (CAPAs). Assist site teams and internal teams in developing CAPAs and improving efficiency. Lead process assessments to improve efficiencies across functional areas. Conduct reviews of documentation required for internal and external audits to ensure compliance with Good Documentation Practices, internal SOPs, and regulations. Qualifications Bachelor’s degree in a related field with 5 years of field monitoring experience. Excellent written and verbal communication, presentation, interpersonal, and analytical skills. Proven problem‑solving and critical‑thinking skills. Demonstrated proficiency in MS Office Suite (Word, Excel, Adobe). Experience with electronic data capture systems. Ability to travel up to 65% of time. Preferred experience in medical device or regulated industry. Preferred experience in cardiovascular research. Preferred clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA). Compensation & Benefits Base salary range: $109,000 – $174,800. Eligible for annual performance bonus and long‑term incentive program. Benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, pension and 401(k) retirement plan. Paid time off: up to 120 hours of vacation, up to 40 hours of sick time (56 for Washington residents), up to 13 days of holiday pay, and up to 40 hours of personal/family time. EEO Statement 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. #J-18808-Ljbffr 6942-ABIOMED Inc. Legal Entity