(Hybrid) Regulatory Operations Manager - WVU Cancer Institute

• Bachelor’s degree in appropriate areas of specialization and three years of experience
• A minimum of three (3) years of experience in the following:
  • Clinical research coordination, regulatory operations, and/or project management
• 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

• Ability to manage multiple concurrent studies and priorities, evaluate operational performance, identify barriers, and implement process improvements. 
• Strong project-management skills, including planning, prioritization, delegation, risk identification, problem solving, and management of timelines and deliverables. 
• Ability to interpret complex protocols, regulations, policies, and sponsor requirements and translate them into operational processes and staff guidance. 
• Proficiency with clinical trial management systems, electronic regulatory systems, IRB platforms, and other clinical research information systems. 
• Strong written and verbal communication, consultation, and interpersonal skills, with the ability to collaborate effectively with investigators, research staff, institutional departments, sponsors, CROs, and external partners. 
• Sound professional judgment and discretion, with the ability to work independently, make decisions, and manage competing priorities in a complex clinical research environment. 

Preferred Qualifications:

• Master’s degree in Clinical Research, Health Sciences, Basic Sciences, Healthcare Administration, or a related field. 
• Three or more years of progressively responsible clinical research experience in an academic medical center, cancer center, research institution, or industry setting. 
• Strong knowledge of federal regulations, ICH Good Clinical Practice, Institutional Review Board requirements, and institutional policies governing human-subject clinical research. 
• Experience with clinical trial activation, including site selection and feasibility, regulatory startup, IRB submissions, ancillary reviews, and coordination of budget, contract, and coverage analysis activities. 
• Experience with ongoing regulatory management of clinical trials, including protocol amendments, continuing review, regulatory document maintenance, sponsor monitoring, audits, and study closeout. 
• Experience with industry-sponsored and National Cancer Institute NCTN/ECTCN cooperative-group clinical trials and associated regulatory and operational requirements. 
• Supervisory, team leadership, project leadership, or other experience coordinating the work of others preferred.