Summary

Oversee the daily operations of clinical research studies and research staff to ensure studies are conducted according to protocol, regulatory requirements, institutional policies, and sponsor expectations. This role supports investigators, manages research personnel, and ensures high-quality patient-centered research operations.

This position requires a balance of operational leadership and hands-on clinical research expertise. The ideal candidate will be skilled in supervising staff while actively contributing to complex study activities and resolving day-to-day research challenges.

Experience in an academic medical center or a multi-specialty research setting is highly preferred. Candidates with a background in managing industry-sponsored, investigator-initiated, and federally funded studies are especially encouraged to apply.

A strong understanding of regulatory requirements is essential, including Good Clinical Practice (GCP), FDA regulations, IRB processes, and human subject protection standards. Experience supporting sponsor audits and regulatory inspections is an advantage.

Familiarity with clinical trial management systems (CTMS), electronic medical records (EMR), and electronic data capture (EDC) systems is preferred.

Based on departmental needs, flexibility is important, as occasional early morning, evening, or weekend hours may be required to support study visits, sponsor meetings, or research deadlines.

Job Duties

• Supervise and support clinical research coordinators, assistants, and other research staff.
• Oversee day-to-day clinical trial operations across multiple studies.
• Ensure compliance with federal regulations, IRB requirements, GCP guidelines, and sponsor protocols.
• Monitor study enrollment, participant retention, and study progress.
• Review and maintain accurate regulatory, source, and study documentation.
• Coordinate study start-up activities, monitoring visits, audits, and close-out procedures.
• Assist with budget tracking, invoicing, and resource allocation.
• Collaborate with principal investigators, sponsors, CROs, and institutional departments.
• Develop and implement standard operating procedures (SOPs) and workflow improvements.
• Train, mentor, and evaluate research staff performance.
• Ensure timely reporting of adverse events, protocol deviations, and study updates.
• Support quality assurance and continuous process improvement initiatives.
• Assisting with budget tracking, invoicing.
• Collaborating with Principal Investigators, Sponsors, CROs and institutional departments.
• Develop and implement standard operating procedures (SOPs) and workflow improvements within the Office of Surgical Research.
• Performs other job-related duties as assigned.

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Bachelor degree with clinical research background.
• Certification CCRP or ACRP is preferred.
• Experience working in an academic medical center or multi-specialty research environment.
• Background managing industry-sponsored, investigator-initiated, and federally funded studies.
• Strong knowledge of regulatory requirements, including GCP, FDA regulations, IRB processes, and human subject protection standards.
• Experience preparing for or supporting sponsor audits and regulatory inspections.
• Familiarity with clinical trial management systems (CTMS), electronic medical records (EMR), and electronic data capture (EDC) systems.
• Flexibility to accommodate occasional early morning, evening, or weekend hours to support study activities and deadlines.
• Prior experience supervising clinical research personnel, including staff development, performance management, and operational oversight, is highly desired.