Protocol Review and Monitoring System (PRMS) & Regulatory Coordinator

Department of Medical Research

This position oversees and facilitates all activities within the Protocol Review and Monitoring System (PRMS) and provides primary support to the Ellis Fischel Cancer Center Protocol Review and Monitoring Committee (EFCC PRMC). The role coordinates Disease Working Group (DWG) activities, which occur during scheduled tumor board meetings, manages the flow of new studies/trials and amendments through PRMC review, and serves as a liaison between investigators, clinical research staff, and administrative teams. The role attends and leads PRMC and DWG meetings, which may occur outside standard business hours.

This professional staff member engages in in-person collaboration and teamwork with clinician investigators across University Hospital, Ellis Fischel Cancer Center and MU School of Medicine (SOM) to facilitate communication, obtain required signatures, deliver documents, speak on incoming trials, and ensure timely completion of regulatory and PRMS-related activities. This role requires proactively going to and meeting clinicians where they are to minimize burden and streamline study operations.

The position supports the EFCC Clinical Trials Office (CTO) regulatory duties and operations, including assisting investigators with timely signatures, in-person communication across MUHC and SOM, and supporting regulatory workload. It manages logistics for site qualification, evaluation, initiation, and monitoring visits. Responsibilities include key submission and review tasks within the OnCore Clinical Research Management System.

Essential Functions:
* Oversee the conduct, documentation, and workflow of EFCC PRMC.
* Collaborate with the PRMC Chair and leadership to maintain and improve PRMC workflows, policies and procedures.
* Guide faculty and staff in submitting materials for administrative and scientific review.
* Validate data quality and consistency within the Clinical Research Management System (CRMS).
* Assist with accrual monitoring and clinical research reporting for leadership.
* Process all PRMC submissions, prepare agendas, determine appropriate actions, and support meeting preparation.
* Support PRMC staff with submission processes and coordinator workflows.
* Arrange and attend PRMC meetings, ensure reviewer participation, and maintain quorum.
* Train new PRMC members on review processes and responsibilities.
* Support DWG meeting preparation, including agendas, trackers, and protocol approval workflows.
* Maintain electronic PRMC documentation and CRMS records.
* Collaborate with OnCore support coordinators to update training materials.
* Assist with educational programs, presentations, and various CTO/OnCore project tasks.
* Support regulatory activities, including reviewing regulatory documents, assisting with Informed Consent Form (ICF) updates, coordinating Principal Investigator (PI)/Sub-Investigator signatures and training, and providing backup for regulatory coordinator responsibilities. I signatures and training, and providing backup for regulatory coordinator responsibilities.

Disease Working Groups (monthly for 7 disease sites)
* Prepare agendas, trackers, pipelines, and enrollment summaries.
* Coordinate new study presentations and feasibility assessments.
* Facilitate discussions on patient populations and accrual potential.

PRMC (monthly)
* Prepare meeting logistics, coordinate scientific/pharmacy reviews, and maintain trackers.
* Manage voting surveys, communicate approvals, support PI submissions, and oversee meeting quorum.
* Submit initial OnCore study build requests.

CTWG (monthly)
* Prepare enrollment, pipeline, and performance reports.
* Maintain the CTO Tracker and Pipeline.
* Coordinate agenda reminders and collaborate with leadership.

Sponsor Visits
* Coordinate schedules, room reservations, and team availability for Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
* Support PIs, coordinators, and data managers with visit requirements.

Incoming Studies and Feasibility
* Coordinate communication with sponsors and complete feasibility questionnaires.
* Track study materials and timelines for DWG/PRMC review.

Audit and CAPA Support
* Draft Corrective and Preventive Action plans (CAPA), coordinate signatures, and support audit responses.

Regulatory Support
* Review regulatory documents, assist with ICF updates, coordinate signatures/trainings, and provide regulatory support.

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

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 in human subject clinical research, knowledge of oncology landscape, and project management.

Salary Range: $18.87 - $30.00 hourly
Grade: GGS - 008
University Title: PROGRAM/PROJECT SUPPRT COOR I
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.

In addition to the Online Application, please provide a Resume/CV.

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 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.

Equal Employment Opportunity

The University of Missouri is an Equal Opportunity Employer.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.