(Hybrid) Regulatory Coordinator - Cancer Institute/Clinical Research Unit

The WVU Cancer Institute/Clinical Research Unit at West Virginia University is currently accepting applications for a (Hybrid) Regulatory Coordinator position.

About the Opportunity

The Protocol Management Office (PMO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is charged with general regulatory and financial oversight of all active WCUCI clinical research studies from open to accrual through termination.

Under the direction of the Protocol Management Manager, the Regulatory Coordinator position is responsible for completing all regulatory activities associated with active industry and cooperative group sponsored clinical studies. The Regulatory Coordinator is also tasked with the start-up of cooperative group sponsored clinical studies.

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% 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

What You'll Do

Cooperative Group Protocol Start-up Activities. The Regulatory Coordinator is responsible for the study start-up activities for cooperative group sponsored protocols. The Regulatory Coordinator:

• Facilitates new protocol submission for disease team and protocol review committee reviews and notifies relevant research staff of approvals
• Prepares and submits new and annual Principal Investigator Worksheets for the NCI CIRB
• Submits Study Specific Worksheets for new protocol to the NCI CIRB and prepares informed consent forms in accordance with Institutional
• Submits new protocols to the WVU IRB for local review and acknowledgement
• Schedules and assists in making materials for site initiation visits
• Creates initial delegation and training logs

Protocol Maintenance Activities. The Regulatory Coordinator is responsible for the lifetime management of all WVUCI industry-sponsored, and cooperative-group sponsored protocols. The Regulatory Coordinator:

• Prepares and submits IRB continuing reviews and amendment reviews
• Updates protocol specific regulatory documents including FDA Form 1572, Financial Disclosure Forms, Delegation Logs, and Training Logs as needed
• Reviews all protocol specific deviations, safety reports, and adverse event reports for reportability, and submits to the IRB when applicable
• Responds to questions regarding regulatory issues, including queries from internal quality review and the Data Safety and Toxicity Committee
• Participates in WVUCI disease team-oriented research meetings, to also include research affiliate network, with investigators and coordinators to ensure prompt and accurate communication of changes in the protocol plan, IRB comments and other regulatory items
• Prepares for study monitoring and auditing visits by reviewing all protocol specific regulatory files and reconciling as needed. Notifies appropriate institutional officials of external audits by FDA and sponsors
• Maintains professional and prompt communications with investigators, coordinators, and sponsors as required

Protocol Closeout Activities. The Regulatory Coordinator is also responsible for coordinating and completing cooperative-group and industry-sponsored protocol closeout activities:

• Reviews and reconciles regulatory files with sponsor monitors
• Coordinates and attends study closeout visits
• Coordinates and attends study close out visits
• Prepares and submits study IRB closures

Professional Development

• Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standards
• Participates in networking opportunities, and continuing education
• Attends conferences when appropriate

• Bachelor's degree in an allied health discipline or related field; or equivalent combination of education and experience
• A minimum of two (2) years of experience in regulatory aspects of industry and government sponsored clinical trials.
• 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 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 manage multiple projects and changing priorities.

• Research Certification with SOCRA or ACRP preferred or able to obtain with in six (6) months of hire.

West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.

From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.

At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values - service, curiosity, respect, accountability and appreciation - unite us as Mountaineers.

Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.

West Virginia University 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.