About the Opportunity
The Clinical Research Coordinator III supports clinical trials (Phases I-IV) at the WVU Cancer Institute by coordinating research activities, ensuring protocol compliance, managing patient care, and maintaining data integrity. The role requires independent judgment, collaboration, and adherence to regulatory standards.
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, 24 annual leave (vacation) days per year, 18 sick days per year, health insurance and other benefits, 401(a) retirement savings with 6% employee contribution match, and wellness programs.
What You'll Do
- Protocol Conduct and Compliance: Ensure compliance with current regulations, guidance and policies at the institutional, state, federal, and international levels. Assess feasibility of implementing new protocols. Collaborate with investigators, research staff, pharmacy, clinical staff and other ancillary departments to implement and conduct trials. Facilitate and participate in monitoring or auditing reviews conducted by internal and/or external agencies such as the U.S. Food and Drug Administration, industry, IRB and quality assurance. Serve as a liaison between the research team, clinical staff, and sponsors. Provide education to staff prior to implementation and throughout the lifecycle of the research study and monitor protocol adherence. Support community outreach and trial advocacy. Collaborate with research team utilizing internal and external resources to develop a recruitment strategy for each research study and evaluate effectiveness.
- Management of Clinical Trial Patients: Ensure the initial and ongoing consent process is performed and documented in compliance with all applicable regulations, guidelines and policies. Educate patients on trial participation, providing updates and information throughout the lifecycle of the study. Assess for barriers to effective informed consent discussion and implement a plan to overcome as barriers are identified. Assess eligibility and monitor patient adherence. Ensure scheduling and adherence to all protocol tests and procedures. Perform study assessments and/or procedures within the employee's scope of practice which may include but not limited to vital signs, ECG, administering questionnaires, etc. Assess and document adverse events in collaboration with the investigator. Collaborate with investigator on dose modifications and treatment responses. Advocate for ethical care of participants while adhering to the protocol requirements.
- Documentation and Training: Maintain accurate source documentation and data reporting. Provide protocol training to clinical staff and/or other members of the research team. Ensure proper documentation practices from clinical staff and provide additional training, as needed. Update the Clinical Trial Management System (CTMS) with protocol and patient information.
- Financial Stewardship: Review trial budgets and coverage analyses for adequacy of funding. Distinguish between routine care and research-related expenses. Ensure patients are reimbursed for research related expenses and/or stipends provided per protocol/contract.
- Professional Development and Leadership: Participates in educational opportunities to increase knowledge about oncology and clinical research. May lead projects or coordinate team efforts. Assist with onboarding and training research staff.
Qualifications
- Bachelor's degree from an allied health discipline, or related medical field (such as nursing, medical technology, pharmacy, etc.)
- A minimum of two (2) years of working in a clinical setting and/or experience 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.
Requirements
- If applicable, valid RN license from the State of West Virginia.
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