GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Alzheimer's Clinical and Translational Research Unit (ACTRU) is a unique group at Massachusetts General Hospital focused on early-stage interventional clinical trials for Alzheimer's disease and related dementias. Under the general supervision of the Program Director, the Regulatory Affairs Coordinator will assist the management team to ensure that regulatory requirements are met for all ACTRU-managed, pharma-sponsored, and investigator-initiated single-site and multi-site clinical research studies (up to 10 active, ongoing studies). They will also coordinate with a Grants Manager to monitor funds and ensure accuracy and compliance, along with contract billing based on deliverables.
Working with the ACTRU management team, the Regulatory Affairs Coordinator will assist the Senior Project Manager in regulatory management, including sponsor and regulatory communication, clinical operations, data management and quality control. Finally, they will work closely with a group of clinical research coordinators on day-to-day operations and team-based study execution to support organizational success.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
WORKING CONDITIONS:
Incumbent will have a shared workspace in Building 149 in the Charlestown Navy Yard and will be assigned a networked computer. The successful applicant may be expected to work from home at times and will be provided with the necessary technology/equipment to allow this.
Primary Location: USA-MA-Charlestown Work Locations: 149 13th Street Charlestown 02129
SKILLS & COMPETENCIES REQUIRED:
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS: CITI or equivalent, GCP preferred.
EDUCATION: Bachelor's Degree required.
EXPERIENCE: None required.