Rsch Mgr -Clin Rsch Coord-RN

About the Job

Position Summary

The Assistant Director of Research
- Clinical Manager provides clinical and operational leadership for the Department of Obstetrics and Gynecology's clinical research program. This position oversees the day-to-day clinical operations and implementation of clinical research studies, ensuring protocols are conducted in accordance with Good Clinical Practice (GCP), applicable regulatory standards, institutional requirements, and departmental goals and priorities.

Working closely with the Director of Research Operations, Vice Chair(s) of Research, departmental leadership, investigators, research staff, sponsors, monitors, and clinical partners, the Assistant Director of Research
- Clinical Manager provides clinical expertise and operational oversight across the department's clinical trial portfolio. The position is responsible for effective management of clinical trials, department-wide study start-up and activation, and supervision and development of clinical research staff.

The Assistant Director of Research
- Clinical Manager serves as a key departmental resource for clinical research operations, supporting investigators in the development and implementation of research studies, monitoring portfolio performance, identifying resource and staffing needs, and developing processes to improve research quality, efficiency, compliance, and participant experience.

Duties/Responsibilities:

Clinical Trial Management - 40%

Provides clinical and nursing expertise to interpret and operationalize research protocols.

Oversees the day-to-day clinical operations and implementation of assigned clinical trials.

Collaborates with Principal Investigators (PIs) and study teams to recruit, screen, and enroll study participants.

Ensures study-required clinical procedures are appropriately executed in collaboration with clinical staff.

Provides or oversees participant education throughout the duration of the study regarding treatment plans, anticipated side effects, monitoring guidelines, and follow-up.

Ensures accurate source documentation, including documentation of research visits in the EMR.

Oversees identification and reporting of serious adverse events, stopping rules, dose-limiting toxicities, and protocol deviations according to institutional and sponsor-required timelines.

Oversees tracking systems for patient visits, protocol-required data collection, and other study procedures.

Troubleshoots operational and clinical challenges in the development and implementation of protocol procedures.

Participates in sponsor, monitor, site initiation, interim monitoring, and closeout visits.

Coordinates with Investigational Drug Services (IDS), Bio Net, clinical staff, laboratories, and other departments across campus to execute study activities according to protocol.

Monitors enrollment, study milestones, visit completion, data collection, and overall trial performance.

Ensures research documentation and protocol compliance are maintained at high standards consistent with monitoring, auditing, and regulatory requirements.

Supports study closeout activities and ensures appropriate reconciliation of study documentation, data, supplies, and other study materials.

Serves as a clinical research resource and subject matter expert for investigators and research staff.

Develops and implements strategies to improve recruitment, retention, study workflows, and overall trial efficiency.

Provides regular updates to departmental leadership regarding clinical trial performance, enrollment, staffing, barriers, and resource needs.

Study Start-Up and Activation - 30%

Provides leadership and oversight for study start-up and activation activities across the Department of Obstetrics and Gynecology.

Reviews protocols and study…