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).
Clinical Trial Coordination
- Recruiting, screening, consenting, and enrolling eligible participants/volunteers for interventional and observational clinical trials.
- Preparing for and coordinating in-person study visits including scheduling of study participants/volunteers, study staff (including physicians and nurses), of clinic space, infusion appointments, and/or imaging appointments under minimal supervision.
- Coordinating with OHSU research pharmacies and assisting with intervention administration.
- Assisting with and/or administration of neurocognitive assessments/tests.
- Collection and entry of study data on case report forms (CRFs).
- Collecting vital signs and blood; Performing EKGs/ECGs.
- Collection and timely reporting of adverse event (AE) data to study sponsors and Institutional Review Boards (IRBs).
- Data entry into study-specific databases and clinical trial electronic data capture (EDC) systems; Responding to EDC queries.
- Collection, processing, storage, and/or shipment of biologic samples (such as blood, urine, and cerebrospinal fluid); Study visit supply organization, inventory checks, and ordering.
- Maintaining communication with study participants/volunteers throughout the trial and follow up period.
- Assisting with study start-up activities, including correspondence with the OHSU IRB and industry sponsor IRBs; administration management in the OHSU clinical trials management system (eCRIS).
- Collaboration with the clinical research billing office to ensure accuracy and completeness; Assisting with billing review and charge reconciliation.
- 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 for and coordination of monitoring visits.
- Ensuring compliance with all protocol and regulatory requirements.
- Recognition of, documentation of, and communication about protocol deviations within sponsor and institutional guidelines.
- 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.
- Must be willing and able serve as a backup for other Layton Center clinical trials Clinical Research Coordinators (Clinical Research Assistants) to provide coverage for time off.
Clinical Research Assistant, Student Worker, and Volunteer Training and Supervision
- Assistance with onboarding and training of clinical research assistants (CRAs), student workers, other staff, and volunteers.
Maintenance of Research, Ethics, Compliance, and Safety Training
- Ensuring that required Collaborative Institutional Training Initiative (CITI) program trainings are complete, up to date, and renewed in a timely manner.