(Hybrid) Senior Clinical Trials Agreement Specialist - Research Office of Sponsored Programs
West Virginia University Research Office of Sponsored Programs is currently accepting applications for a Senior Clinical Trials Agreement Specialist.
About the Opportunity
This position will serve as the designated lead for clinical trial agreements in the Award Negotiation sub-department. The Office of Sponsored Programs (OSP) is the central administrative unit charged with providing support to the WVU community in the solicitation, acquisition, and administration of externally funded projects for research, teaching, and service. This position in the OSP Award Negotiation sub-department is responsible for reviewing and negotiating grants, contracts, and other agreements to confirm that the terms and conditions: protect the interests of WVU faculty members and students, protect WVU's institutional interests, are consistent with WVU's policies and mission statement, and are consistent with all applicable state and federal laws.
OSP Award Negotiation works 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 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
- 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 (this position is a benefits-eligible non-classified staff position)
- 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 Lead Duties:
- Manage and oversee all clinical trial agreement activities for the Award Negotiation sub-department.
- Manage clinical trial agreement work assignments for the Award Negotiation team.
- Facilitate the clinical trial process between the WVU Clinical Trials Center of Excellence and OSP.
- Employ professional judgment and independent decision-making skills to prepare and negotiate clinical trial agreements that protect the interests of WVU.
- Develop, maintain, and deliver clinical trial agreement training and guidance materials for the Award Negotiation sub-department.
- Develop and facilitate trainings for WVU faculty and staff on the clinical trial process.
Award Negotiation Duties:
- Independently review contractual documents (e.g., agreements, purchase orders, grant awards) ensuring that all terms and conditions are acceptable to WVU, the WVU Research Office, the WVU Research Corporation, the WVU Board of Trustees, and the Principal Investigator.
- 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 Director of OSP, Associate Director of Award Negotiation, Associate VP for Finance, Operations, and Research Administration, and the Vice President for Research.
- Prepare and send letters of exception to sponsors, describing any terms and conditions that are unacceptable, suggesting alternative terms, and providing justification for revision.
- Manage issues consistent with WVU procedures and objectives.
- 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 regarding sponsored programs 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), and the Office of Export Control upon completion of the review process.
- Contact sponsors and researchers to establish rapport, understanding and/or information, as well as to facilitate the use of the organization's services.
- Employ professional judgment and independent decision-making skills to prepare and negotiate subcontract agreements that protect the interests 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.
- Establish subcontract payment schedules to create mandatory audit documentation and ensure efficient cashflow.
- Apply organizational policies and procedures to resolve moderate to complex matters.
- Apply independent judgment and resourcefulness to adapt to the business circumstance.
- Provide internal and external customer service to include addressing sponsor and customer verbal and written inquiries.
- Make referrals to the OSP website or the appropriate WVU staff and/or faculty for additional information to state, federal, or other government agencies and departments, and other sponsors of research.
- Facilitate daily communication with the Award Negotiation Associate Director, sponsors, and WVU faculty and staff.
- Provide program, as well as direct internal and external client, support services.
- Independently respond to inquiries.
- Coordinate with the Manager of the Award Initiation and Management sub-department to assist with the establishment of sponsored awards within ORACLE.
- Facilitate the progression of the award lifecycle from Award Negotiation to the Award Initiation stage by providing clear, substantive documentation highlighting unique post-award management requirements, and provide information sufficient to issue subawards, as necessary.
- Utilize the OSP electronic research administration platform to create and locate reference documents, activity, and route logs.
- Utilize the OSP electronic research administration platform to maintain meticulous records.
- Prioritize time-sensitive material for appropriate action.
- Build and maintain positive business relationships with internal and external customers, including college, department, and center leaders.
- Collaborate with OSP Pre-Award and Award Initiation sub-departments to help move forward initiatives related to OSP's goals and enhance the level of success in achieving OSP's overall objectives.
- Ensure proper follow-up to requests pertaining to the review of sponsored research agreements.
- Respond to faculty inquiries regarding OSP Award Negotiation procedures.
- Develop and maintain subrecipient monitoring materials, including subrecipient commitment forms and other resources for vetting subaward institutions at the subaward stage.
- Perform rotating Award Negotiation tasks, including monitoring and responding to general inquiries received by the Award Negotiation vanity email accounts, ensuring appropriate and timely responses.
- Create and maintain OSP website content, including developing training resources for faculty/staff, Standard Operating Procedures, and OSP guidelines for Award Negotiation content.
- Develop and present training or informational programs and presentations.
- Assist with drafting and maintaining award negotiation manuals and guidance to ensure consistency and compliance by the WVU community.
- Assist in the development of creating information and supportive documents for OSP.
- Proactively make recommendations for improvements to OSP and WVU processes and procedures.
- Attend on and off campus meetings as necessary concerning OSP and report back on issues of importance. Serve on committees and task forces as directed.
- Prepare and present reports as directed.
- Master's degree in social sciences, liberal arts, law or related discipline with 2 years of experience OR bachelor's degree with 4 years of experience.
- Two (2) years of experience with master's degree or four (4) years of experience with bachelor's degree in research administration and/or legal-rated experience with contracts.
- 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 OSP, 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.
- Maintain skills in, or knowledge of, professional principles, legal and/or reporting requirements affecting area of responsibility.
- Ability to write routine reports and correspondence.
- Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others.
- Manages difficult or emotional matters with objectivity and openness; responds promptly to needs and requests for service and assistance; meets commitments and dates, notifies others if change occurs; provides, solicits and applies feedback; and builds goodwill through balanced contributions, positive approach, respect and support of others.
- Demonstrated group presentation skills, participates in meetings, listens and gets clarification, is responsive and speaks clearly and persuasively in positive and negative situations. Writes and edits clearly and informatively, varies style to meet needs, presents numerical data effectively, and able to read and interpret written information.
- Aligns work and develops strategies to meet organizational goals; seeks to improve and promote quality; demonstrates accuracy and thoroughness; and upholds organizational expectations and values.
- Responds to management direction; resourcefully adapts to changes in work environment and circumstances; responds well under pressure and manages competing demands; takes calculated risks, asks for and offers help when needed; exercise discretion and sound judgment; is tactful and responsible for own actions.
- Adheres to work schedule and complies with leave management responsibilities.
- Excellent communication and listening skills.
- Excellent time management skills.
- Excellent interpersonal skills to interact with various customers throughout WVU.
- Demonstrated ability to work independently and appropriately apply discretion.
- Demonstrated problem solving skills.
- Demonstrated knowledge of research administration.
- Demonstrated ability to understand and appropriately apply Federal, State, and University policies and procedures, and interpret cost principles.
- Demonstrated to use basic math and/or accounting skills.
- Juris Doctor from a U.S. American Bar Association - accredited law school is preferred.
- 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.
- Certified Research Administrator, preferred.
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.
Job Posting: Sep 12, 2023
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes