Function/Duties of Position
Layton Center clinical trials team Clinical Research Regulatory Coordinators (TI Senior Clinical Research Assistants) are highly organized and are responsible for duties related to supporting human subject research trials, including various regulatory needs. Regulatory Coordinators must effectively and professionally communicate (verbally including by phone and video call as well as in writing) within the Layton Center clinical trials team, with other departments at OHSU including the IRB, and with study sponsors and contract research organizations (CROs). Regulatory Coordination
- Continuing Reviews – Preparation and IRB submission of annual continuing reviews in collaboration with the Layton Center clinical trials team
- Modifications – Preparation and IRB submission of updates to protocols, consent forms, etc. in collaboration with study sponsors and CROs
- Reportable New Information (RNI) Reports – Preparation and IRB submission of RNI reports
- Staff Changes – IRB submission of staff changes
- Site Feasibility Questionnaires & Communication – Management of sponsor inquiries for potential trials including completion of site feasibility questionnaires
- Study start-up activities, including initial submissions to OHSU IRB and industry sponsor IRBs; administration management in the OHSU clinical trials management system (eCRIS).
- Assisting with study close-out activities
- Routine correspondence with the OHSU IRB and industry sponsor IRBs related to required submissions, protocol modifications, and continuing reviews.
- Regulatory document and binder maintenance in compliance with Good Clinical Practice (GCP) standards.
- Preparation and maintenance of personnel sheets, delegation logs, and FDA Form 1572
- Assistance with preparation for and coordination of monitoring visits.
- Ensuring compliance with all protocol and regulatory requirements.
- Attending, actively participating in, and providing updates at recurring Layton Center clinical trials team meetings.
- Assisting leadership with ensuring consistent project management, complex logistics, quality assurance, and participant safety.
- Assistance with onboarding and training of clinical research assistants (CRAs), student workers, other staff, and volunteers – specifically related to duties involving regulatory work.
- Ensuring that required Collaborative Institutional Training Initiative (CITI) program trainings are complete, up to date, and renewed in a timely manner.
- Bachelor’s degree in relevant field AND 1 year of relevant experience OR Associate’s degree AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience
- Relevant experience must include regulatory activity experience
- Working knowledge of scientific methods and human subjects research
- Intermediate or advanced knowledge of Word, Excel, Outlook, and other MS Office programs
- Demonstration of high level of attention to detail; self-starter; ability to prioritize work demands and manage time appropriately
- Demonstrated high level of organization and ability to efficiently manage multiple tasks
- Able to perform the essential functions of the position with or without accommodation
- Must possess excellent written and verbal communication skills; be able to multi-task and enjoy working in a team
- Therapeutic intervention clinical trial experience strongly preferred
- SOCRA, CCRP or ACRP certification preferred