New Job (Hybrid) Senior Clinical Trials Agreement Specialist - Wv Clinical & Translational Science Institute In West Virginia

The WV Clinical & Translational Science Institute (WVCTSI) at West Virginia University is currently accepting applications for a hybrid Senior Clinical Trials Agreement Specialist.

About the Opportunity

As a Senior Clinical Trials Agreement Specialist, you will perform legal review and negotiation of clinical trial agreements at West Virginia University (WVU) under the supervision of the Director and Lead Negotiator (J.D.) of the Clinical Trial Agreement Team located within WVCTSI. The WVCTSI and its Clinical Trials Center of Excellence provides the infrastructure that facilitates participant safety and regulatory compliance while providing efficiency that drives growth of cutting-edge clinical research at WVU. This position reporting to the leadership of WVCTSI is responsible for reviewing and negotiating legal transactions specific to the intake (Non-Disclosure and Confidentiality Agreements), administration (Clinical Trial Agreements or CTAs), and facilitation (Data Use Agreements or DUAs) of clinical research at WVU. You will review legal transactions as assigned by WVCTSI leadership to confirm that the terms and conditions: protect the interests of WVU faculty members and students; protect WVUs institutional interests; and are consistent with WVUs policies, mission statement, contractual limitations as an agency of the State of West Virginia, and all applicable state and federal laws.

This position will be expected to collaborate and work with leaders in a variety of compliance departments, including, but not limited to, the Export Control Office, the Office of Technology Transfer, the Office of Sponsored Programs, the Office of Human Research Protection, the Office of Animal Welfare, and WVU General Counsel. Work effort has considerable impact on client services, program and project image, and with potential legal liabilities.

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 or more based on years of service (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:

Clinical Trial Duties:

• Manage and oversee the legal review and processing of clinical trial agreement activities at WVU.
• Manage clinical trial agreement work assignments to prioritize contracts as directed by WVCTSI leadership in order to meet site enrollment or other deadlines.
• Facilitate the clinical trial process on behalf of the WVU Clinical Trials Center of Excellence and other compliance departments at WVU.
• Employ professional judgment and independent decision-making skills to prepare and negotiate clinical trial agreements that protect the interests of WVU.
• Independently review contractual documents (e.g., NDAs, CDAs, DUAs, grant awards) that are not CTAs but necessary to facilitate the clinical research enterprise at WVU, ensuring that all terms and conditions are acceptable to WVU.
• Employ professional judgment and independent decision-making skills to negotiate terms and conditions with sponsors based on university policies and under the supervision of the WVCTSI and in collaboration with the Office of General Counsel, Office of Sponsored Programs, Office of Technology Transfer, as applicable.
• Negotiate terms and conditions with sponsors, describing any terms and conditions that are unacceptable, suggesting alternative terms, and providing justification for revision.
• Work with appropriate agency and sponsor contacts to ensure that corrections and/or exceptions are incorporated into the terms and conditions, as directed.
• Using in-depth knowledge of university policies and procedures to provide guidance to faculty and staff as they may relate to compliance issues including, but not limited to, export control, data security and data use, and human subjects.
• Independently ensure that proper approvals are obtained from the Institutional Review Board (IRB) for the Protection of Human Subjects, the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), the Office of Export Control, Information and Technology Services (ITS), and the WVCTSI Risk Assessment Committee (RAC) upon completion of the review process.
• Employ professional judgment and independent decision-making skills to prepare and negotiate subcontract agreements applicable to clinical research that protect the interests of WVU by ensuring that subcontract agreements are in compliance with the prime sponsor guidelines, contractual requirements, federal regulations, including Uniform Guidance and federal funding accountability and transparency act (FFATA) requirements, and University policy considerations in the areas of intellectual property, copyright, insurance, governing laws, indemnification, and payment schedules.
• Independently assess sponsor type, activity, and statement of work to determine the appropriate flow-down clauses.
• Assess subrecipient eligibility and risk.
• Apply organizational policies and procedures to resolve moderate to complex matters.
• Apply independent judgment and resourcefulness to adapt to the business circumstance.

WVCTSI Customer Service:

• Make referrals to the appropriate WVU staff to facilitate the prompt processing of clinical trials at WVU. Identify and raise issues for leadership review consistent with WVU procedures and objectives.
• Facilitate daily communication with WVCTSI leadership, sponsors, and WVU faculty and staff. Timely contact and communicate updates to sponsors and researchers to establish rapport and facilitate the use of WVCTSI’s Clinical Trial Center of Excellence services.
• Provide program, as well as direct internal and external client, support services.
• Independently respond to inquiries.
• Provide internal and external customer service to include addressing sponsor and customer verbal and written inquiries.
• Support the development and delivery of clinical trial agreement training and guidance materials for other personnel that support the clinical trial review process at WVU.
• Develop and facilitate trainings for WVU faculty and staff on the clinical trial process.
• Other duties as assigned by the Director and Lead Negotiator (J.D.) of the Clinical Trial Agreement Team located within WVCTSI.

• Juris Doctor from a U.S. American Bar Association accredited law school.
• A minimum of two (2) years of legal-related experience with contracts between academic medical research centers or hospital systems or research institutes and the private sector.
• Interpreting federal regulations, including a working knowledge of export control laws and regulations.
• Interpreting complex legal terms and conditions and research accordingly.
• Knowledge of federal regulations related to clinical research, including NIH regulations covering NIH funded inventions.
• Working knowledge of federal and state regulatory and compliance issues, federal and state laws, and public policy.
• Working knowledge of Institutional Review Board (IRB) regulations.
• Ability to read and interpret documents such as Federal Acquisition Regulations (FAR), DFAR, Code of Federal Regulations (CFR), OMB Circulars, and other regulatory documents.
• Ability to learn academic, administrative, and organizational policies and procedures that impact WVCTSI, with the ability to apply these policies and procedures to daily work assignments.
• Ability to apply judgment, discretion, and initiative in coordinating many different and complex tasks, determining relative importance of each, setting priorities, and completing project in a timely fashion.
• Ability to interact with other WVU departments, including WVU General Counsel, and various funding agencies with tact, courtesy, and confidentiality in order to resolve pre-award or contract issues.
• Ability to utilize a variety of software packages.
• Ability to work accurately under short deadlines.

Preferred Qualifications:

• Clinical Trial Agreement (CTA) experience.
• Experience in writing contracts.
• Experience in Research or Healthcare compliance.
• Experience working in an administrative/business office in a university, hospital, or research institute.

At West Virginia University, we leverage our talents and resources to create a better future for our state and the world. As West Virginia's land-grant university, WVU has three campuses that touch each corner of the state. The WVU System includes 518 buildings on 15,880 acres, Extension Service offices in all 55 counties, ten experimental farms and four forests.

From the groundbreaking R1 research of our flagship campus in Morgantown to the career-oriented programs of WVU Potomac State in Keyser to the technology-intensive programs at WVU Tech in Beckley — the contributions of WVU employees directly impact the 1.8 million people of West Virginia every day, no matter their role or position.

Service, curiosity, respect, accountability, and appreciation are the core values that unite Mountaineers, inspiring one another to work tirelessly and support others as they seek to reach new heights. After all, when you're a Mountaineer, impossible is just another mountain to climb.

Creating an inclusive, engaged, and dynamic learning environment is core to WVU’s academic mission. We welcome candidates who can contribute a range of ideas, approaches and experiences.

To learn more about West Virginia University, visit go.wvu.edu. View current career opportunities at careers.wvu.edu.

West Virginia University is proud to be an Equal Opportunity employer and is the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff, and students, and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.