Purpose Statement / Position Summary The Regulatory Affairs Coordinator I (RAC I) will assist the clinical study team(s) with the administration and regulatory compliance of clinical research. Responsibilities will include regulatory preparation, maintenance and support for MemorialCare clinical research protocols. Projects may include industry- sponsored, federally-funded, and/or investigator-initiated studies.
Essential Functions and Responsibilities of the Job
Work with principal investigator(s) to develop, draft, and compile research protocol
documents and all materials required for regulatory submissions in compliance with Food and Drug
Administration (FDA) and local Institutional Review Board (IRB) policies.
Assure all site documents, including SOPs and administrative files, are maintained
in audit-ready condition.
Remain informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.
Be at work and be on time.
Follow company policies, procedures and directives.
Interact in a positive and constructive manner.
Prioritize and multitask.
Essential Job Outcomes
Coordinate regulatory activities for multiple clinical research projects.
Assist in obtaining initial documents for clinical trial procurement and site selection.
Develop the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol.
Compile research protocol documents and all materials required for regulatory submissions in compliance with institutional and federal policies.
Oversee new study initiation process and provide regulatory guidance/support throughout the duration of the project.
Demonstrate strong written and verbal communication skills.
Escalate issues in a timely manner and communicate outcomes effectively across impacted team members.
Revise submissions in response to identified problems and resolve issues in a timely manner;
inform clinical research team on revisions and remedies.
Report pertinent safety data and deviation notifications (Unanticipated Problem report) to
Maintain current and accurate documentation in the regulatory binder as well as the dedicated electronic study folder.
Participate in required teleconferences, on-site meetings and off-site investigator meetings, as required.
Maintain working knowledge of current protocols and internal SOPs.
Attend continuing education and training opportunities relevant to job duties.