(Hybrid) PRMS Program Coordinator - WVU Cancer Institute/Clinical Research Trials

West Virginia University

1d • Hybrid

About The Position

The WV Cancer Institute/Clinical Research Trials at West Virginia University is currently accepting applications for a (Hybrid) Protocol Review and Monitoring System (PRMS) Program Coordinator
About the Opportunity
The Protocol Review and Monitoring System (PRMS) is a required entity for all NCI-designated cancer centers, with the following primary responsibilities: ensuring adequate scientific review is performed for all clinical research protocols, determining feasibility of new research and adequate accrual to open studies. PRMS oversees the scientific integrity of clinical research to align with the priorities of the WVU Cancer Institute (WVUCI) including scientific rigor, innovation, and equity.
The PRMS Program Coordinator will support a broad range of PRMS Program area processes. Responsibilities include coordinating the Disease oriented research team meeting agendas and minutes, Protocol Review and Monitoring Committee (PRMC) agendas and presenters, ensuring documentation of reviews and approvals, dissemination of committee decisions, and bridging teams and guiding risk-based oversight of cancer research protocols.
We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:
• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ’s.
• Wellness programs

Requirements

• Bachelor’s Degree
• A minimum of two (2) years of experience in the following:
• Program management, administrative support, research coordination and/or project management in clinical research.
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.
• Able to present and maintain a professional, polished, and positive demeanor/disposition while working with internal and external stakeholders in a dynamic, high-paced environment.
• Excellent organizational skills and the ability to problem solve and multi-task.
• Excellent customer service and relationship management skills.
• Able to work independently with minimal supervision but remain consistent with the PRMS requirements established by the NCI and the interpretation of those requirements by the WVUCI's leadership.
• Excellent interpersonal and communication skills, both written and verbal.
• Well-organized and extremely detail oriented. Ability to manage competing deadlines and re-shift focus as necessary.
• Strong problem-solving skills.
• Ability to work with faculty across the campus and external partners.
• Is responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including day to day administrative functions.
• Proficient typing skills.
• Proficient with Microsoft Office Suite including Outlook, Word, and Excel.
• Knowledge in writing and grammar.

Nice To Haves

• Master’s degree in business, health, public health, science, public administration, or related field
• Progressively responsible project manager experience
• Research Certification with SOCRA or ACRP preferred
• Experience working in a higher education, research and/or academic medical environment.
• Knowledge of clinical research operations and the conduct of clinical trials
• Experience with electronic clinical trial management systems
• Experience working with NCI, Industry, and Investigator-Initiated trials.

Responsibilities

• Provide high level strategic and operational oversight to WVUCI in fulfilling all CCSG Protocol Review and Monitoring System (PRMS) requirements, ensuring the program not only meets but anticipates evolving NCI expectations.
• Shape the long term vision for PRMS by identifying emerging regulatory trends, assessing institutional readiness, and advising leadership on strategic investments in systems, staffing, and process modernization.
• Oversee the scientific review infrastructure for all clinical research protocols, ensuring that review pathways support scientific rigor, patient safety, feasibility, and alignment with institutional research priorities.
• Represent PRMS as a trusted institutional authority, communicating program goals, standards, and compliance expectations to faculty, staff, sponsors, and external reviewers.
• Lead the development, implementation, and continuous refinement of PRMS policies, SOPs, and governance frameworks to strengthen institutional research oversight and maintain NCI designation.
• Direct the full operational lifecycle of protocol submission, review, approval, and ongoing monitoring, ensuring that workflows are efficient, transparent, and responsive to investigator needs.
• Provide leadership in planning, coordinating, and facilitating Disease Team and PRMC meetings, ensuring that agendas reflect institutional priorities, reviewers are prepared, and decisions are well documented and actionable.
• Ensure the accuracy, completeness, and timeliness of all PRMS documentation, including meeting minutes, disposition letters, reviewer comments, and protocol specific materials.
• Oversee the integrity of clinical trial management system (CTMS) data by ensuring timely entry of protocol information, review outcomes, amendments, and sponsor updates.
• Manage high volume communications through the PRMS shared inbox, ensuring timely triage, resolution, and escalation of inquiries from investigators, research staff, and external partners.
• Maintain a robust operational infrastructure that supports audit readiness, regulatory compliance, and seamless coordination across multiple research units.
• Lead quality assurance initiatives by conducting systematic reviews of PRMS processes, identifying inefficiencies, and recommending improvements that enhance scientific rigor and operational performance.
• Develop and maintain comprehensive tracking systems, dashboards, and performance metrics to support leadership decision making, CCSG reporting, and institutional oversight.
• Monitor low accrual studies in collaboration with leadership, ensuring compliance with CCSG guidelines and contributing to strategic decisions about study continuation, closure, or redesign.
• Support the preparation and submission of CCSG applications, annual progress reports, and competing renewals, providing data, narratives, and documentation that demonstrate PRMS effectiveness.
• Participate in NCI site visits and serve as a knowledgeable representative of PRMS operations, able to articulate processes, outcomes, and continuous improvement efforts.
• Ensure PRMS remains compliant with federal regulations, institutional policies, and best practices in oncology research oversight.
• Build strong, collaborative relationships with investigators, regulatory teams, data managers, and clinical trial staff to ensure protocols are scientifically sound, feasible, and aligned with institutional capabilities.
• Work closely with committee chairs and scientific reviewers to categorize clinical trials by risk level, ensuring appropriate review pathways and resource allocation.
• Provide training, guidance, and consultative support to faculty and staff on PRMS procedures, submission requirements, and best practices in protocol review and monitoring.
• Serve as a liaison between PRMS and other institutional units—including regulatory affairs, clinical operations, and data management to ensure cohesive and efficient research oversight.
• Facilitate communication between investigators and reviewers, helping resolve questions, clarify expectations, and streamline the review process.
• Represent PRMS in institutional working groups, committees, and cross departmental initiatives aimed at strengthening research governance and operational excellence.
• Stay current with evolving NCI guidelines, regulatory requirements, and best practices in oncology research administration by participating in workshops, conferences, and professional development programs.
• Engage in internal leadership development and data management training to enhance expertise and contribute to the growth of the research enterprise.
• Support PRMS leadership with high level administrative functions, including preparing presentations, reports, spreadsheets, and other materials that support strategic planning and program evaluation.
• Contribute to a culture of continuous learning by sharing knowledge, mentoring colleagues, and participating in institutional training initiatives.
• Strengthen institutional research capacity by helping develop protocol specific tools, process flows, training manuals, and educational resources for investigators and staff.

Benefits

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks.
• Wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level