Senior Clinical Research Regulatory Coordinator, Clinical Investigation
Mass General Brigham
- Boston, MA
- Permanent
- Full-time
- Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
- Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies and offices.
- Prepares, maintains and organizes regulatory files for each assigned study in compliance federal and local regulations including study sponsor requirement, institutional requirements and good clinical practice guidelines.
- Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
- Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third-party auditors.
- Expertise in project management related to tracking and managing assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.
- Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed
- Create and maintain tracking for all subsequent submissions to the SRC / IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exceptions or other event reporting. Ensure various regulatory reporting required are met; Study Sponsor, FDA, IRB etc.
- Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable
- Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol, consent and amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable
- Extensive knowledge of federal and state regulations governing clinical research, and good clinical practice guidelines, regulatory guidance and local policies
- Lead and collaborate with CCCI staff to implement regulatory and study based training and implementation of new or revised regulation, guidance and or local policy
- Present regulatory status for disease group portfolio at applicable research meetings
- Values diversity, integrity and confidentiality
- Exercises self-awareness; monitors impact on others; is receptive to and seeks out feedback; uses self-discipline to adjust to feedback.
- Accountable for delivering high quality work
- Commitment to ongoing learning to produce safe, effective, quality outcomes,