New

Clinical Research Activation Coordinator II

Mass General Brigham (Enterprise Services)
United States, Massachusetts, Boston
101 Merrimac Street (Show on map)
Oct 01, 2025
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 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.