Senior Protocol Review and Monitoring System (PRMS) Coordinator

The department of Medical Research with in the School of Medicine

Position directs and coordinates activities within the Protocol Review and Monitoring System (PRMS). Provides direct support to the Ellis Fischel Cancer Center Protocol Review and Monitoring Committee (EFCC PRMC). Assists in supporting the activities of the Disease Working Groups. Responsible for facilitating the flow of new submissions, revisions, amendments, and renewals through PRMC review. Serves as PRMC lead coordinator, acts as liaison between investigators and departmental staff, and assists with database development. This position will provide support and training for the Ellis Fischel Cancer Center Clinical Trials Office personnel and investigators using the OnCore Clinical Research Management System (CRMS) to conduct human subject clinical research.

Essential Functions:

1. Oversees conduct and documentation of EFCC PRMC.

2. With PRMC Chair, oversees policies and procedures for the committee. Responsible for assisting in the development of policies and procedures, as applicable.

3. Provides guidance to faculty/staff in submitting appropriate research-related documents to the PRMC, which includes administrative and full board scientific review of cancer studies.

4. Validates data entered into the Clinical Research Management System (CRMS) and ensures consistency in recording and reporting.

5. Works with PRMC Chair in fulfilling the committee's accrual monitoring functions.

6. Assists MU SOM and EFCC leadership with preparing clinical research reports and ongoing monitoring of metrics and data validity.

7. Processes incoming submissions and determines appropriate action, e.g., verifies completeness, prepares master agenda, determines approval status, approves paperwork, assists with meeting preparation, etc.

8. Provides guidance to other PRMC staff on submission processes, meeting preparation, and coordinator workflow.

9. Arranges/attends PRMC meetings and queries reviewers for attendance at meetings (to ensure quorum).

10. Meets with new committee members to educate them on the review process; assists members as needed to fulfill responsibilities and meet deadlines of PRMC meetings.
11. Responsible to assist with other aspects of the Protocol Review and Monitoring System, to include assisting Clinical Research Nurses and Manager, Clinical Trials Office to prepare Disease Working Group (DWG) meeting agendas and to track DWG protocol approvals for submission to PRMC.

12. Responsible for building and maintaining cancer clinical trials within the OnCore system.

13. Responsible for training and support of EFCC CTO staff and applicable other end users in the use of the OnCore CRMS, serving as liaison between Information Technologists who support OnCore and the end users.

Other Functions:

14. Prepares and maintains electronic files, including PRMC management within CRMS.

15. Works with other OnCore Program/Project Support Coordinators within the School of Medicine to update OnCore CRMS training materials.

16. Assists in planning and implementing educational programs and presentations.

17. Assist with other OnCore/CTO project maintenance tasks as assigned.

18. Safety officer duties, including coordinating safety reports from central clinical trials teams.

8am - 5pm Monday - Friday, with occasional other hours, including evenings, or weekends, as required by study protocols or workload.

Flexibility for Alternative Schedules: No

A Bachelor's degree or an equivalent combination of education and experience and 1 year of experience from which comparable knowledge and skills can be acquired is necessary.

Two years' experience with human subject clinical research process, project management software, and training individuals on use of new software programs is preferred.

Hiring Range: $18.50 - $26.00
Grade: GGS-008
University Title:PROGRAM/PROJECT SUPPORT COORDINATOR I
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.

In addition to filling out the online application please provide a resume.

Columbia offers small-town friendliness with big city features and a high quality of life for people of all ages and interests. Founded on education and known as an ideal college town, its location also makes it an attractive spot for businesses and travelers. Located on Interstate 70 and U.S. Highway 63, Columbia is right in the middle of the state and the nation. Just a couple hours' drive from St. Louis and Kansas City, Columbia is Boone County's largest population center offering big-city culture, activities, and resources with a low cost of living. Columbia is home to a variety of restaurants and entertainment venues and hosts more than a dozen cultural festivals each year. If you want to grow your career, continue your education, raise a family, and retire, Columbia is a good place to be!

This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty & Staff Benefits website at https://www.umsystem.edu/totalrewards/benefits.

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In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research, and engagement.

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