Clinical Research Activation Coordinator II

Mass General Brigham•Boston, MA

37d•$24 - $39•Remote

About The Position

The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Clinical Research Activation Coordinator II (CRAC II) works independently under general supervision to ensure the regulatory and operational requirements for clinical trials are met prior to activation. This position may also involve post-activation regulatory responsibilities. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRAC II will be trained on the institutional and federal regulations governing clinical research. This position does not include any direct patient contact. 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.

Requirements

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
Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required
Regulatory Affairs Experience 2-3 years required
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.

Responsibilities

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.
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.
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.
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.