Clinical Research Activation Coordinator II

Mass General Brigham (Enterprise Services)
United States, Massachusetts, Boston
101 Merrimac Street (Show on map)
Oct 01, 2025
Principal Duties and Responsibilities: The following activation duties will be performed independently under general supervision by the Clinical Research Manager: Maintain the priority list of upcoming studies and closely track timelines from receipt of protocol to study activation. Conduct Pre-Site Qualification visits with sponsors and complete feasibility questionnaires. Complete the Activation Checklist to ensure all involved entities are ready for study enrollment. Attend Site Initiation Visits and track all pending items identified during the visit. Review protocols to determine operational feasibility of required elements. The following regulatory duties will be performed independently under general supervision by the Clinical Research Manager: Maintain and organize study specific electronic regulatory files Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process Collect, complete, and submit essential regulatory documents to various regulatory entities. Ensure appropriate documentation of delegation and training for all study staff members. The following regulatory duties may be performed independently under general supervision by the Clinical Research Manager: Participate in monitoring visits and file all monitoring visit correspondence. Submit relevant dose cohort updates to the IRB. Submit Data and Safety Monitoring Reports. Maintain screening and enrollment logs. Route all amendments to relevant reviewers and coordinate completion of all signoffs required for activating amendments. Skills/Abilities/Competencies Required Ability to work independently and as a team member Analytical skills and ability to resolve problems Ability to interpret acceptability of data results Careful attention to detail Good organizational and communication skills High degree of computer literacy *Working knowledge of clinical research protocols Education Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Regulatory Affairs Experience 2-3 years required Knowledge, Skills and Abilities - Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g., ICH E6, 21 CFR, etc.). - Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data integrity. - Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously. - Excellent written and verbal communication skills. - Proficiency in using relevant software and electronic systems for regulatory documentation management. - Ability to interpret the acceptability of data results. Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.