[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Johnson & Johnson is a leading healthcare company focused on innovative solutions for complex diseases. They are seeking a Senior Clinical Research Associate to coordinate clinical study activities, mentor junior staff, and ensure compliance with clinical protocols and regulations.

Responsibilities

• Coordinate study start-up and study conduct activities, including drafting study-specific templates and plans, developing study-specific essential documents lists, managing and communicating the status of study progress and activities
• 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 team (e.g., clinical data management, medical safety) with query management and data entry/submission
• Assist project management team with advanced responsibilities, including monitoring visit report reviews, reviewing study metrics, conducting trainings, etc
• Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees
• Mentor and train junior employees, including conducting co-visits and collaborative report writing
• 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 problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
• Verify trial/study data, including maintaining appropriate regulatory documents both internally and externally, ensuring the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded
• Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements
• Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition
• Provide oversight of and insight into trial activities (e.g., trends in protocol noncompliance, enrollment, data quality) to clinical sites and study management/leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Data Management, Safety, Contracts/Budgets, etc
• Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
• Assist site teams and internal study team with the development of corrective and preventative actions (CAPAs), when required
• Lead in assessing current and new processes, finding opportunities and implementing solutions to improve efficiencies within and across related functional areas
• 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
• Prepare materials for steering, investigator, and research coordinator meetings

Skills

• Bachelor's Degree in related field with 5 years of previous field monitoring experience required
• Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
• Proven problem-solving and critical thinking skills
• Demonstrated expertise in MS Office Suite, including Word, Excel, Adobe
• Experience with electronic data capture
• Ability to travel up to 65% required
• Experience working in a medical device or regulated industry preferred
• Experience working in cardiovascular research
• Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification) preferred

Benefits

• Annual performance bonus in accordance with the terms of the applicable plan
• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
• Participate in the Company’s consolidated retirement plan (pension) and savings plan (401k)
• Eligible to participate in the Company’s long-term incentive program
• 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

Company Overview