Protocol Review & Monitoring Coordinator
DescriptionUniversity of Colorado | CU Anschutz Medical Campus
School of Medicine, The Cancer Center
Protocol Review and Monitoring Coordinator
Research Services Intermediate Professional
Position #779821 – Requisition #19602
This position is responsible for the collection, interpretation, and documentation of clinical research data to facilitate the protocol monitoring responsibilities of the Protocol Review and Monitoring System (PRMS) at UCCC. An approved PRMS is a requirement of all NCI-designated cancer centers and assures appropriate scientific merit review and monitoring of all clinical research protocols. Professional Field
Research Compliance and Regulatory AdministrationExamples of Work Performed
- Abstracts and records all research data pertaining to the accurate monitoring of scientific progress and underrepresented populations enrolled on UCCC studies, to facilitate evaluation by PRMS leadership
- Query data from available electronic platforms (i.e. TriNetX®, OnCore®) to evaluate the feasibility of conducting new studies submitted to PRMS
- Act as liaison between PRMS and Study Teams
- To ensure proper protocol decision documentation is collected and filed
- To reconcile team records with PRMS records and communicate any discrepancies found
- Coordinates and meets data deadlines
- Updates clinical trial management system(s) and performs data Quality Assurance checks as appropriate
- Create training process documents
- Completes administrative tasks requested by Supervisor, as necessary
- Coordinates and facilitates PRMS meetings and arranges conference room details and conference call information.
- Serves as administrative PRMS representative to internal and external audiences regarding PRMS activities.
The salary range begins at $46,609.This position is not eligible for overtime compensation.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator: http://www.cu.edu/node/153125Diversity and Equity:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoo[email protected] The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
- Bachelor’s Degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration or related fields of study.
- One (1) year of medical, clinical and/ or research experience
- Research experience (oncology is a plus)
- Experience with OnCore and/ or TriNetX a plus
- Experience working with NCI, Industry and Investigator-Initiated trials.
- Experience working in an academic and/or medical environment.
- Ability to problem solve and multi-task
- Well-organized and extremely detail oriented
- Able to interpret and master complex research protocol information
- Intermediate to Advanced Microsoft Office skills (MS Word, Excel, Outlook)
- Ability to work independently, but remain consistent with the PRMS requirements established by the NCI and the interpretation of those requirements by the UCCC leadership
- Excellent interpersonal and communication skills, both written and verbal; proficient typing skills
- Ability to manage competing deadlines and re-shift focus as necessary; is open to new ideas and methods; is able to work independently and as part of a team
- Ability to work with faculty across the campus and external partners
- Is responsible for exercising discretion and personal accountability in a wide range of areas including day to day administrative functions.
- Possesses knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to the conduct of clinical trials
Job Category: Research Services
Primary Location: Aurora
Posting Date: Nov 19, 2020
Unposting Date: Ongoing