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:

• Preparation and submission of clinical trial amendments to the IRB (i.e. central IRB, SMART IRB, MGB IRB) across multiple studies (amendments, consent forms, protocol summaries, subject materials). This may include other study documents received from industry sponsors throughout the course of the study, as well as smaller amendments to keep documents and processes up-to-date.
• Collection, completion, and submission of regulatory documents to various regulatory entities. This includes collecting signatures and information from participating investigators and providing them to industry sponsors.
• Creation and maintenance of regulatory binders and other relevant files during the activation process for new trials.
• Revisions and in some cases creation of informed consent documents.
• Correspondence with the IRB, investigators, and sponsors from start-up to close-out.
• Preparation of annual progress reports for IRB renewal of ongoing studies.
• Assists with IND submissions and amendments to the FDA.
• Ensures archival of study documents, storage of binders and supplies, and oversees readiness for audit by MGH Research Compliance or the FDA.
• Assists with regulatory aspects of data storage and EDC databases.
• Mentors junior staff on regulatory aspects of clinical trial regulatory processes.
• Assists with formal audits/QC of data and maintains internal QI program.
• Attends project meetings and collects and distribute minutes when necessary.
• Regularly attend MGB Compliance and Regulatory meetings to stay up to date on MGB's Responsible Conduct of Research Training and Compliance requirements.
• Serves as a resource for all compliance-related matters, providing guidance and support as needed.
• Assist with the OnCore billing process for Clinical Trial invoicing and help manage the revenue under Clinical Trial accounts.
• Assures compliance with federal purchase and contract requirements.

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:

• Preparation and submission of clinical trial amendments to the IRB (i.e. central IRB, SMART IRB, MGB IRB) across multiple studies (amendments, consent forms, protocol summaries, subject materials). This may include other study documents received from industry sponsors throughout the course of the study, as well as smaller amendments to keep documents and processes up-to-date.
• Collection, completion, and submission of regulatory documents to various regulatory entities. This includes collecting signatures and information from participating investigators and providing them to industry sponsors.
• Creation and maintenance of regulatory binders and other relevant files during the activation process for new trials.
• Revisions and in some cases creation of informed consent documents.
• Correspondence with the IRB, investigators and sponsors from start-up to close-out.
• Preparation of annual progress reports for IRB renewal of ongoing studies.
• Assists with IND submissions and amendments to the FDA.
• Ensures archival of study documents, storage of binders and supplies, and oversees readiness for audit by MGH Research Compliance or the FDA.
• Assists with regulatory aspects of data storage and EDC databases.
• Mentors junior staff on regulatory aspects of clinical trial regulatory processes.
• Assists with formal audits/QC of data and maintains internal QI program.
• Attends project meetings and collects and distribute minutes when necessary.
• Regularly attend MGB Compliance and Regulatory meetings to stay up to date on MGB's Responsible Conduct of Research Training and Compliance requirements.
• Serves as a resource for all compliance-related matters, providing guidance and support as needed.
• Assist with the OnCore billing process for Clinical Trial invoicing and help manage the revenue under Clinical Trial accounts.
• Assures compliance with federal purchase and contract requirements.

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS: CITI or equivalent, GCP preferred.

EDUCATION: Bachelor's Degree required.

EXPERIENCE: None required.