Regulatory Affairs Coordinator - Urology

Mass General Brigham•Boston, MA

3d•$20 - $29•Hybrid

About The Position

The Regulatory Affairs Coordinator I works 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.

Requirements

Bachelor's Degree Related Field of Study required
Experience can be accepted in lieu of a degree
Careful attention to detail.
Good organizational skills.
Ability to follow directions.
Computer literacy.
Working knowledge of clinical research protocols.

Responsibilities

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.
Maintains regulatory documentation for assigned studies in accordance with institutional requirements, sponsor requirements, federal regulations, and GCP guidelines.
Manage adverse events and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
Submit Data and Safety Monitoring Reports.
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.
Participate in monitoring visits and file all monitoring visit correspondence.
Tracks regulatory deadlines and study milestones, including continuing reviews, protocol amendments, personnel changes, training expirations, and other required submissions.
Works with Clinical Research Coordinators, investigators, and other study team members to collect information and documentation needed for regulatory submissions.
Maintains current study personnel documentation, including CITI/GCP training, CVs, medical licenses, delegation of authority logs, conflict-of-interest documentation, and other required records.
Assists with maintaining study information in applicable institutional research systems and regulatory tracking tools.
Prepares and maintains electronic and/or paper regulatory binders and ensures documents are complete, current, appropriately signed and dated, and readily available for review.
Assists with processing study personnel additions and removals and ensures corresponding regulatory documentation and systems are updated.
Supports submission and tracking of protocol deviations, safety reports, reportable events, and other regulatory documentation under the guidance of senior regulatory staff.
Communicates with study teams regarding upcoming regulatory deadlines and outstanding documentation.
Maintains accurate regulatory tracking spreadsheets and databases.
Assists with regulatory study close-out activities and maintenance of required records.
Other duties as assigned.