Join our team as the Institutional Review Board (IRB) Protocol Coordinator!
The IRB Coordinator will join the Clinical Research Support (CRS) team dedicated to supporting clinical researchers across USC schools. Today we are expanding to continue meeting the health needs of our community. Our patients, their families and our staff are all part of a unified effort to advance findings that will solve life-changing diseases. This is what inspires our staff to be their best—and they’re equipped with everything they need to succeed.
The IRB Protocol Coordinator provides personalized assistance, education/training and support to USC investigators and study personnel who are putting together a protocol and application for submission to the USC IRB. As such, this position will work closely or in conjunction with the USC IRB.
This person will also assist with the preparation and submission of regulatory and compliance-related documents (such as IND/IDE applications) to the sponsor or funding agency in conjunction with services already being provided by USC Regulatory Knoweldge and Support.
In an educational capacity, this person will provide ongoing training to investigators, research coordinators, research nurses, and other clinical research personnel as it pertains to regulatory and compliance-related issues.
Any available time not spent on regulatory activites will be spent assisting ongoing clinical research studies supported by CRS coordinators. These activities may include consenting patients, scheduling patients, participant recruitment, data entry, administering questionnaires, REDCap database building, and more. Finally, the job also includes assisting the CRS Program Manager with administrative tasks as needed, and assisting the CRS Director with CTSI-related projects as needed.
***This is a grant-funded, 1-year fixed term position supported by the National Institute for Health (NIH)***
50% Coordinates and supports IRB activities:
- Coordinator will assist investigators and study personnel with preparing their IRB protocol application and with the protocol submission process
- Coordinator will educate and train PIs and study staff on best practices for protocol development, protocol application submission, iStar, etc.
- Reviews study protocols and assists with writing sections of the application, or providing detailed guidance for how to write sections
- Provides assistance with writing informed consent and assent documents when needed
- Will assist PIs with obtaining institutional approvals for DUAs and other data-related regulatory requests, ancillary committees such as radiation safety, biosafety, etc.
- Assists with preparation and submission of protocol amendments, continuing reviews, and closeouts
- Provides education for how to respond to IRB contingencies
- Answers regulatory and compliance-related questions from study staff and PIs
- Assists and advises as needed with conflict of interest processes for PIs
- Working closely with USC IRB, CRS Director and/or Program Manager on tasks as needed
50% Coordinate and supports research projects and CRS program activities:
- Coordinator will assist with project-related activities and duties for clinical research studies as needed depending on demand from CRS group (may include but is not limited to coordinating patient visits, consenting patients, recruitment, data collection, building REDCap databases, etc).
- Assists CRS Director & Program Manager in administrative capacity as needed; helps with CTSI-related projects
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.
Knowledge, Skills and Abilities
- Working knowledge of institutional requirements pertaining to the preparation and submission of IRB applications at USC.
- Working knowledge of process and regulations associated with FDA, NIH, DHHS, ICH GCP, etc.
- Knowledge of preparation and submission of regulatory/compliance documents to study sponsors and federal agencies.
- Maintains current knowledge of federal research regulations.
- Ability to provide meaningful, impactful education and training to PIs and their study staff.
- Collaborates with USC IRB director, analysts and other regulatory and research personnel.
- Maintains competence and engages in ongoing opportunities for professional development. Maintains license, certification or registration as required.
- Performs other duties as requested.
- Prior experience working on clinical trials with both industry sponsors and federal funding agencies.
- Prior experience working with a diverse patient population.
Preferred Education, Training, & Experience
- Master’s degree
- ACRP/SOCRA certification
- Prior experience working in medical/clinical research settings
- 3-5 years of experience as a research coordinator working on clinical studies involving human subjects
- Minimum two years experience as research coordinator working on clinical studies involving human subjects
- Experience with preparing and submitting IRB applications
- Spanish fluency
To apply, contact Nicki Karimipour at email@example.com