Hybrid Regulatory Operations Lead – Clinical Trials

West Virginia University; Morgantown (WV); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

West Virginia University’s Cancer Institute in Morgantown seeks a Hybrid Regulatory Operations Manager to oversee protocol activation and regulatory lifecycle across industry-sponsored and cooperative-group trials. You will lead staff, coordinate startup activities, and ensure compliance with IRB, sponsor, and institutional requirements.

The role emphasizes workload planning, performance metrics, SOP development, and cross-functional collaboration with CRU and WVU leadership to improve

Qualifications

• Bachelor's degree in appropriate areas of specialization; three years of clinical research regulatory operations or related experience.
• Master's degree in Clinical Research, Healthcare Administration, or related field preferred.
• Experience with regulatory submissions, sponsor requirements, and regulatory documents.

Responsibilities

• Oversee staff in protocol activation and ongoing regulatory management.
• Ensure timely study startup, regulatory compliance, and workload distribution.
• Develop workflows, training resources, and SOPs for regulatory operations.
• Coordinate with investigators, sponsors, and institutional departments to resolve issues.

Skills

Regulatory operations

Project management

Staff supervision

Regulatory compliance

Education

Bachelor's degree in relevant field

Master's degree in Clinical Research or related field

Tools

CTMS

IRB platforms

Electronic regulatory systems

Job description

West Virginia University’s Cancer Institute in Morgantown seeks a Hybrid Regulatory Operations Manager to oversee protocol activation and regulatory lifecycle across industry-sponsored and cooperative-group trials. You will lead staff, coordinate startup activities, and ensure compliance with IRB, sponsor, and institutional requirements.

The role emphasizes workload planning, performance metrics, SOP development, and cross-functional collaboration with CRU and WVU leadership to improve