(Hybrid) Investigator-Initiated Trials Project Manager - WVU Cancer Institute/Clinical Research Trials

The WVU Cancer Institute/Department of Clinical Research Trials at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Investigator-Initiated Trials Project Manager.

About the Opportunity

The Protocol Development Office (PDO), a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU), is responsible for the activation and management of clinical research protocols conducted at the WVUCI. A primary focus of the PDO is the development, coordination, and oversight of Investigator-Initiated Trials (IITs), serving as the central IIT Management Team for all WVUCI single- and multi-site IITs.

Under the direction of the Protocol Development Manager, this Project Manager position is dedicated to IITs and is primarily responsible for the coordination and full lifecycle management of WVUCI-led multi-site IITs, ensuring regulatory and operational oversight from protocol development and start-up through trial execution and closeout across all participating sites.

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

Investigator-Initiated Trial Protocol Development and Start-Up Activities. The IIT-focused Project Manager is responsible for coordinating and completing IIT protocol development and start-up activities:

• Collaborate with investigators on IIT concept development and protocol drafting using institutional templates
• Lead the creation of informed consent forms in compliance with FDA, ICH, and GCP guidelines
• Support submission of Letters of Cross Reference and IND applications to the FDA, as needed
• Manage development of regulatory documents and submission to IRB and FDA
• Present IITs to disease teams and PRMC
• Partner with Business Coordinator on budget and contract execution when applicable
• Develop trial specific manual of procedures along with clinical team
• Ensure the Electronic data base and data safety monitoring plans are validated, and instructions provided.
• Schedule and help prepare materials for site initiation visits for multi-site IITs

Investigator-Initiated Trial Management (Ongoing Trial Oversight). A primary responsibility of the IIT-focused Project Manager is the management of WVUCI multi-site IITs:

• Lead the regulatory and operational management of multi-site WVUCI IITs across their full lifecycle, serving as the primary liaison between the lead institution (WVUCI) and affiliate institutions
• Coordinate and submit IRB continuing reviews, amendments, and safety reports on behalf of the lead institution and ensure required communications with affiliate institutions are maintained
• Prepare and submit FDA annual reports for IITs conducted under an IND, including integrating data and updates from all affiliate institutions
• Ensure maintenance of complete and compliant regulatory documentation across all institutions; respond to regulatory and operational queries from collaborators, sponsors, and oversight committees
• Coordinate and facilitate remote and on-site monitoring visits and audits across the study institutions, addressing compliance concerns in collaboration with institutional partners
• Manage closeout activities for IITs, including submission of IRB and FDA closure documents for both the lead and affiliate institutions
• Provide centralized project oversight to ensure consistency, quality, and regulatory compliance across all sites involved in WVUCI-led multi-site IITs

Professional Development

• Participate in ongoing training to stay current with institutional policies, clinical research regulations (FDA and ICH-GCP guidelines), and best practices
• Attend relevant workshops, conferences, or webinars to support growth in project coordination, regulatory compliance, and protocol development
• Engage in cross-functional learning opportunities within the WVUCI and the broader WVU research community

• Bachelor's degree in an allied health discipline or related field.
• A minimum of two (2) years of experience in the following:
  
  
  
  • Research experience in an academic clinical research facility or industry research facility and/or medical/clinical training.
  • Prior experience managing projects with multiple moving parts and stakeholders
  
  
  
  
• 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

• Understanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subject clinical trials
• Strong desire to learn, seek out, and apply new knowledge, methods, and information.
• Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, WVUCI staff, and others.
• Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills.
• Proven sense of professional ethics and conduct, understanding and effectively using and applying Emotional Intelligence strategies and skills.
• Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capability.
• Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Proficiency with Microsoft Office suite, particularly Outlook, Excel, Word.
• Working knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulations.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to manage multiple projects and changing priorities.

Preferred Qualifications:

• Master's Degree in an allied health discipline
• Research Certification with SOCRA or ACRP

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 an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.