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 the IRB.
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.
Other duties as assigned.
Minimum of one (1) year of experience in the field of regulatory documentation management or clinical research required.
Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes functionality required.
Excellent interpersonal and communication skills required.
Experience submitting IRB applications (initial submissions and amendments) preferred.
Knowledge of clinical trial federal, state and local regulations preferred.
Associates degree or equivalent education required.
Bachelor’s degree in relevant field preferred.
Research certification (e.g. RAPS, ACRP, SoCRA or equivalent) preferred.
Current CITI training certification preferred.
Internal Number: MEM003110
Let us introduce ourselves. We're MemorialCare, a nonprofit health system that includes four hospitals, two medical groups, imaging centers, surgical centers and much more. As one of the leading health systems in Orange County and Los Angeles County, we're confident that no matter what your needs are, we have the teams, tools and know-how to support you every step of the way.