Assistant Director of Clinical Trials COE - Quality Assurance - WVCTSI - Hybrid
West Virginia University Research Corporation

Description

West Virginia University Research Corporation is currently accepting applications for an Assistant Director of Clinical Trials Center of Excellence (COE) - Quality Assurance with the WV Clinical & Translational Science Institute (WVCTSI). 

About the Opportunity

As Assistant Director of Clinical Trials Center of Excellence (COE) - Quality Assurance, you will be responsible for ensuring internal quality, regulatory compliance, regulatory system support and effective training programs for WVU Health Sciences clinical trials. You will plan, create, implement, and coordinate the quality assurance, auditing and training policies and procedures across the Clinical Trials Center of Excellence (COE).

 You will perform a variety of independent and collaborative duties related to clinical trial oversight and will participate in building research infrastructure through collaboration with other WV Clinical & Translational Science Institute (WVCTSI) cores to contribute to the overall mission of the WVCTSI of improving health outcomes for West Virginia.  

This position allows for flexibility in work location, including potential hybrid or remote work / work from home options. Travel to the WVU Campus may need to occur based on organizational needs throughout the year.

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!!

• In collaboration with the COE Director, develop institutional standard operating procedures and/or work instructions and training on a number of topics relevant to clinical trial conduct for research teams and principal investigators. 
• Assist with oversight of the institutional clinical research quality management system and processes, including internal audits and corrective action/preventive action (CAPA) program. Collaborate with research teams across the institution on improvement initiatives to ensure Good Clinical Practices compliance.
• Provide input to COE Director on clinical trial compliance trend analysis related to areas of potential regulatory institutional risk and propose innovative solutions such as novel regulatory systems, training programs and other quality improvement initiatives.
• Lead continuous efforts for institutional compliance with Clinicaltrials.gov registration and reporting.
• Provide guidance on clinical research regulatory system (e.g., OnCore, eReg) acquisition, validation, training, and support across the WVU research community.        
• In collaboration with the Director and/or Assistant Director of the COE, ensure timely review of COE clinical trial registrations, facilitate the risk assessment committee (RAC) and appeal committee preparation. Attend RAC and Appeals Committee meetings in a supportive role.
• May participate as a member of the Senior Clinical Research Executive Committee, as needed.
• May assist with the Tactical Advisory Committee (TAC) mission to ensure representation across the WVU research community to bring forth issues and topics for input, discussion, process improvement and fostering communication, policies/procedures as the clinical research quality representative. 
• Assist with clinical trial-related Regulatory Agency or Sponsor audits and serve as subject matter expert for in-service training on Regulations and Good Clinical Practice guidelines.  
• Supervise quality/regulatory affairs programmatic support staff who deliver clinical research support services to clinical trial investigators and their research teams.  

• Bachelor's degree in a science, nursing, healthcare administration or other related biomedical discipline OR an equivalent combination of education and directly related experience.
• A minimum of five (5) years of experience in regulatory and/or quality aspects of pharmaceutical and/or medical devices industries or government sponsored clinical research studies; two (2) of which must include supervisory or program management experience.
• 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 CRF) & 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.
• Skill in supervising personnel including organizing objectives, delegating responsibilities, training, evaluating subordinate effectiveness, and administering necessary discipline.
• Knowledge of regulatory system validation and processes in support of clinical research.
• Skilled at problem solving.
• Excellent oral and written communication skills.
• Skilled at creating and implementing effective quality management system programs with application of GCP regulations and risk assessment.
• Demonstrated ability for gap analysis and leading training programs and other quality improvement initiatives related to increased clinical research quality and efficiencies.
• 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.
• 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.

• Certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) or a Quality Assurance organization (e.g., SQA).

• Medical Monitoring -- This position may or may not require Medical Monitoring, including periodic health monitoring and/or training.