(Hybrid) Protocol Review Monitoring System Coordinator (PRMS) - Cancer Institute/Clinical Research Trials - West Virginia University Research Corporation
Morgantown, WV
About the Job
Description
The WVU Cancer Institute/Clinical Research Trials at West Virginia University Research Corporation is currently accepting applications for a Protocol Review and Monitoring System (PRMS) 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, and dissemination of committee decisions.
At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:
• 13 paid holidays (staff holiday calendar)
• Paid Time off (PTO)
• 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)
• A range of health insurance and other benefits
• Dependent Education Scholarship
• WVU Perks
What You'll Do
- Provides direct operational support to the WVUCI leadership in coordinating all required CCSG PRMS elements.
- Serves as administrative representative to internal and external audiences regarding PRMS activities, providing advice, guidance and training as needed to various members of the clinical research community (faculty and staff) on PRMS's procedures and submission requirements
- Addresses all inquiries to the PRMS shared email inbox.
- Master the various study types and reviews required for each study submission, allowing for appropriate identification and triage of study review.
- Coordinates and facilitates Disease team as well as PRMC meetings including:
- Prepares agendas, takes meeting minutes, and creates and sends disposition letters.
- Reviews all disease team and PRMC applications for completeness and accuracy.
- Collects and organizes all documentation related to PRMS submissions and ensures all necessary documentation is in place for review.
- Arranges conference room (Zoom) details and conference call information as needed.
- Updates clinical trial management system(s) with new protocol entry, disease team and PRMC submission and approval dates, amendments, new sponsor information, uploading documents, and any other necessary information.
- Files all electronic documents in the appropriate systems.
- Identifies issues related to operational efficiency and provides input to leadership regarding process improvement
- Assist with developing or develops protocol-specific systems and documents including process flows and training manuals.
- Create and maintain tracking and reporting tools for PRMS.
- Works with leadership in the monitoring of low accrual studies as per NCI Cancer Center Support Grant (CCSG) guidelines.
- Assists WVUCI leadership in the write up and submission for initial CCSG application. Upon CCSG funding, provides information for the annual non-competing renewal and the competing renewal and participates in the site visit performed by the National Cancer Institute as part of the 5-year renewal process.
- Performs administrative and office support activities to PRMS leadership. Duties may include fielding telephone calls, word processing, creating spreadsheets/ presentations, and filing.
Qualifications
- Associate's Degree
- A minimum of two (2) years of experience in program assistant position, administrative support, research coordinator 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.
Knowledge, Skills and Abilities
- 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.
- 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.
Preferred:
- Bachelor'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.
The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.
The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.
West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
