Serves as the liaison between sponsors, external IRBs, research coordinators, study teams, legal, grants and contracts, and project management for external research studies. Under the general supervision of the Director of Research Compliance, will coordinate all aspects of the process by which research involving human or animal subjects is reviewed to ensure compliance with institutional and federal policies and regulations.
Required Minimum Knowledge, Skills, and Abilities (KSAs)
- Responsible for External IRB Informed Consent Form reconciliation.
- Communication (emails and voicemails) triage and management for External IRB projects.
- Maintenance or establishment of the Master Language Documents.
- Assist with development of forms and templates for the Office of Research Ethics and Compliance.
- Assist with review of Reportable New Information investigations.
- Assist with the development of reliance agreements.
- Maintains and updates the Reliance agreement excel sheet.
- Other duties as required.
Bachelor's degree plus 6 months relevant experience; OR 3 years relevant experience.
Certified IRB Professional preferred.
Detailed knowledge of regulations regarding the use of human and animal subjects.
Communication and interpersonal skills needed to work closely and effectively with principal investigations, committee members and administrative personnel.
Strong written and oral communication skills.
Strong independent thinking and complex problem solving skills.
Working knowledge of MS Office products, including MS Word and MS Access.
May act as the manager in the manager's absence.
Maine Medical Center is a Magnet designated 606-bed tertiary care and teaching institution. MMC is Maine's largest hospital and a state-wide health care resource. MMC offers outstanding career opportunities and quality of life in Portland.