The West Virginia Clinical and Translational Science Institute (WVCTSI) at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Training Manager.

About the Opportunity

The training manager is responsible for the training program development and training support across the West Virginia Clinical and Translational Science Institute (WVCTSI) and Clinical Trials Center of Excellence (COE). Programs may be interdisciplinary in nature and will require strategy development and planning across multiple areas. Training initiatives are highly visible to WVCTSI constituents and are a key component of the infrastructure-building mission of the organization. This position reports to the Assistant Director of ISCORE-Resource Center (RC) Clinical Research Coordinator Development Program (CRCDP).

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)
• 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
• And More!!

What you'll do:

• Responsible for designing, developing, coordinating, and conducting the training for all training programs for the Clinical Trials Center of Excellence, in collaboration with COE leadership, including an onboarding curriculum, continuing education and competency-based training. Examples of these programs include the Clinical Trials Toolkit series and the Principal Investigator's Academy among other initiatives.
  
• Develop appropriate training materials on diverse topics.
• Manage and prioritize WVCTSI training needs across different cores.
• Market and effectively deliver or facilitate training to clinical research operational groups and investigators as part of investigator educational programs using various training methods and activities.
  
• Assist with coordination of components of the Principal Investigators Academy.
• Advise WVCTSI and COE leadership on training gaps by conducting training needs analyses to determine specific training needs for clinical research staff and supporting departments to meet objectives of the institution. Lead continuous improvement training, including for trends identified via the quality system
• Evaluate effectiveness of training programs
• Stay abreast of available training platforms and methods (digital and in person) and advises on best modes of training facilitation.
• Analyze training documentation systems/databases, including cost/benefit, and assist with the implementation and/or be responsible for maintenance of learning system educational material
• Research, analyze, and recommend external training programs as needed to provide opportunities for ongoing development.
  
• Maintain records of training activities and employee progress and contribute to program metrics.
• Collaborating with the communications team for development of marketing/promotional materials
• Responsible for creating status reports on project/program plans, progress, and results of activity, including coordination of quarterly and annual required reports. Monitor, evaluate, or record training activities or program effectiveness
• Assist with revisions to Policies and Standard Operating Procedures
• Participate in building research infrastructure through collaboration with other WVCTSI cores to contribute to the overall mission of the WVCTSI of improving health outcomes for West Virginia.

• Bachelor's degree, or an equivalent combination of education and experience.
• A minimum of five (5) years of experience as a trainer and/or in a regulated pharmaceutical or government-sponsored clinical research study setting.
• Working knowledge of regulatory aspects of pharmaceutical and medical devices industries and government sponsored clinical research studies including institutional review board (IRB) regulations, US FDA Code of Federal Regulations (US FDA CFR) & Guidances, National Institute of Health (NIH), International Conference on Harmonization (ICH) GCP, Medicines and Healthcare Products Regulatory Agency (MHRA), Therapeutic Products Directorate (TPD) or Health Canada, etc.
• Ability to measure and assess staff training needs and effectively develop and deliver training material.
• Knowledge and understanding of traditional and modern training methods (mentoring, e-learning, workshops, simulations, etc).
• Excellent oral and written communication skills.
• Strong problem-solving, risk assessment and impact analysis abilities.
• Strong work processing skills and understanding and the ability to handle stress and work under pressure.
• Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Strong time management skills and ability to prioritize and manage multiple projects simultaneously.
• Computer proficiency and familiarity with use, including Microsoft Office.
• Skilled at leading and supervising others.
• Demonstrated ability to work effectively in both cross-functional teams and independently is required.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Must be able to read and understand large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.

• The ability to travel to WVUs regional campuses and/or within the multi-state area is required.

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.

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

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.