Clinical Research Activation Coordinator II
 Massachusetts General Hospital | |
 United States, Massachusetts, Boston | |
| 101 Merrimac Street (Show on map) | |
 Mar 14, 2026 | |
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Summary
Works independently under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. Will be trained on the institutional and federal regulations governing clinical research. This position does not include any direct patient contact. Does this position require Patient Care? No Essential Functions -Monitor and maintain compliance with applicable local, national, and international regulations, as well as institutional policies and guidelines related to clinical research. -Prepare, review, and submit all necessary regulatory documentation required for initiating and conducting clinical trials. -Facilitate the submission of study protocols and related documents to the Institutional Review Board (IRB) or Ethics Committee, ensuring compliance with ethical and safety considerations for human subjects involved in the research. -Maintain accurate and up-to-date regulatory documentation, including informed consent forms, protocol amendments, safety reports, and other essential study-related documents. -Prepare and submit timely and accurate regulatory reports, including adverse event reports and safety updates, as required by regulatory authorities and institutional policies. -Act as a liaison between the research team, principal investigators, sponsors, and regulatory authorities. -Provide guidance and training to research staff, investigators, and study team members on regulatory matters, best practices, and changes in regulations that may impact the conduct of clinical research. Education Physical Requirements
The General Hospital Corporation 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. | |