The USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a Protocol Review and Monitoring System Administrator to join its team.
The Protocol Review and Monitoring System (PRMS) is a requirement for all National Cancer Institute (NCI)-designated Comprehensive Cancer Centers. The charge of the PRMS is to review all research studies in areas of diagnosis, therapy, supportive care, prevention, and cancer control that have not received traditional peer review for scientific merit. PRMS also monitors all cancer research studies in the institution for scientific progress and, as such, has the authority for closing any studies that are not meeting accrual or performance standards.
The Protocol Review and Monitoring System (PRMS) administrator provides administrative and operational support to the Protocol Review and Monitoring System (PRMS) including step 1 which is the disease team review and step 2 which is the scientific review by the Clinical Investigations Committee (CIC). This is a full-time exempt position responsible for the coordination of the Norris Cancer Comprehensive Center (NCCC) Clinical Investigational Committee (CIC) and a CIC subcommittee, known as the Scientific Progress and Accrual Monitoring Subcommittee (SPC). The CIC performs the initial scientific review of all cancer clinical trials conducted at NCCC. The SPC monitors accrual according to an established accrual monitoring policy after the trial is approved and activated.
Key Responsibilities include:
- Coordinate all activities related to PRMS functions and processes.
- Leads the successful implementation of all PRMS processes using basic planning techniques.
- Establish and maintain ongoing compliance with review and documentation processes, policies, and procedures.
- Serve as a point of contact for sponsors, investigators, and disease team managers for the submission of new cancer related protocols to the scientific review committee (CIC).
- Ensure cancer related trials are reviewed by the CIC in a timely manner
- Track the progress of protocols submitted to the CIC until they are approved and handed over to the regulatory team
- Provide assistance to the committee chair(s) in coordinating and conducting committee meetings
- Coordinate schedules, formulate agendas, prepare materials for committee meetings and maintain committee meeting minutes
- Prepare committee memos to provide to principal investigators (PIs) with the committee study review outcome.
- Ensure PIs address committee requests in a timely manner
- Continually assess the PRMS process to identify any issues and potential ways to improve it
- Coordinate and facilitate SPC meetings
- Track scientific progress and accrual of ongoing studies and provide update to SPC
- Ensure SPC recommendations are followed and implemented
- Establish and maintain on-going compliance with review and documentation processes, policies and procedures.
- Assist in developing and provide training on the PRMS processes, as needed, for both committee members and investigators submitting new studies for review.
- Provide PRMS data as needed for various purposes including for CCSG annual non-competing and the competing renewal grants.
- Perform related duties as assigned or as required to successfully fulfill functions of the position.
- Perform any other tasks assigned by the supervisor or CISO management to improve PRMS, department performance, processes & procedures. CISO reserves the right to add or change duties at any time.
- Minimum Education: Bachelor’s degree
- Experience coordinating operational logistics for high-level scientific and clinical meetings utilizing teleconference and web conference technology.
- Ability to work both independently and as part of team
- Takes initiative and demonstrates strong commitment to duties.
- Demonstrates the ability to multi-task, prioritize, and work within a deadline-driven structure
- Ability to analyze problems and implement solutions.
- Exhibits attention to detail and strong organizational skills
- High-level communication skills to convey information in a clear and concise way
- Experience and understanding of clinical trial processes and clinical trial protocols
- Training and/or education in health related field which allow for basic mastery of terminology and principles involved in health research
- Ability to capture verbal discussions accurately and write clearly for the purpose of generating meeting minutes and memos to investigators
- Preferred Education: Master’s degree
- NCI Comprehensive Cancer Center committee administration experience
- Education and/or training in principles of health research
- Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored.
- Experience with clinical trial management systems (CTMS)
Special Instructions to Applicants:
Applicant Attachments (Required): Cover Letter and Résumé
Applicant Attachments (Optional): Letters of reference
The annual base salary range for this position is $101,821.40 – $127,896.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.
Additional Education Requirements
Combined experience/education as substitute for minimum education
3 years of related experience with specialized research and/or programs.
Addtional Experience Requirements
Combined experience/education as substitute for minimum work experience
Related experience with specialized research and/or programs (e.g., counseling, teaching).
Ability to analyze and evaluate data, and present findings.
Excellent interpersonal and written and oral communication skills, able to problem solve and lead conflict resolutions.
Ability to interpret and apply policies/analyses/trends.
5 years of related experience with specialized research and/or programs.
Related special education, licensing, or certifications based upon program content and services.
Proven ability to lead and guide others.
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