The Southern California Clinical and Translational Science Institute (SC CTSI) is a research organization at the University of Southern California (USC) and Childrenâsâ Hospital Los Angeles (CHLA).Â Our mission is to support, promote and accelerate scientific discoveries and their application in real-life settings to improve health in diverse populations. SC CTSI develops and provides resources, services, training and tools in support of researchers, academic leadership and partners that collaborate to achieve this exciting mission.
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 bestâand theyâre 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
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
Minimum Education: Bachelor's Degree, Combined education/experience as substitute for minimum educationMinimum Experience: 1 year; Combined education/experience as substitute for minimum experienceMinimum Field of Expertise: Relevant research experience.
USC’s Viterbi School of Engineering has been one of the economic engines in Southern California and a vital hub in the California economy. The technical innovations and ideas generated by the Viterbi faculty and research community have resulted in countless innovations, many becoming the foundations for new companies, products and services. The thousands of students graduating each year bring new ideas and vitality to companies in California and beyond. With an annual research budget exceeding $205M each year, more than 46 research centers and institutes, more than 180 faculty members, 7,800 students and over 60,000 impassioned alumni world-wide, the Viterbi School is addressing some of the world’s great challenges.