Clinical Research Project Manager B/C (OBGYN - Pregnancy and Perinatal Research Center)

About the role

This position will support funded research projects for the Pregnancy & Perinatal Research Center under supervision of the Director of Clinical Research Operations. The primary role of this position is the organization, coordination, and implementation of multiple clinical research studies. The role is based in Philadelphia, Pennsylvania within the Perelman School of Medicine.

Responsibilities

• Develop study workflows and coordinate participant visits, testing, and appointment coverage in accordance with study protocols and Good Clinical Practice (GCP) guidelines.
• Provide operational oversight for one or more large-scale clinical research studies, including the creation and maintenance of study logs, calendars, and tracking tools to support recruitment, retention, and study milestones.
• Lead implementation of new and existing study protocols, including developing operational plans and training research staff on study procedures and integration into existing workflows.
• Design, develop, and maintain case report forms (CRFs) and databases in REDCap; train research staff on proper data collection and documentation procedures.
• Monitor data quality, completeness, and timeliness; identify and resolve data discrepancies; provide real-time feedback and training to research staff to ensure compliance with study and sponsor requirements.
• Prepare and submit regulatory documents, including protocol modifications, deviations, continuing reviews, and other Institutional Review Board (IRB) submissions.
• Train and mentor research staff on regulatory processes and IRB submission requirements, as appropriate.
• Supervise assigned research personnel, including performance management, completion of annual evaluations, approval of leave requests, onboarding, training, and professional development.
• Collaborate with other project managers to ensure consistent performance expectations and effective cross-coverage among research staff.
• Partner with clinical and operational staff to facilitate the seamless integration of research activities into clinical operations.
• Collaborate with PPRC leadership to develop, implement, and maintain center-wide Standard Operating Procedures (SOPs) that promote consistent, compliant, and efficient research operations.
• Lead process improvement initiatives across multiple research projects to enhance operational efficiency, study quality, regulatory compliance, and staff productivity.
• Serve as a liaison between project managers and leadership to communicate operational concerns, identify training needs, and promote consistent practices across research teams.

Qualifications

Clinical Research Project Manager B: BA/BS degree with 5 to 7 years of experience or Master’s degree with 3 to 5 years of experience in research and clinical study methodologies, or equivalent combination of education and experience is required. Clinical Research Project Manager C: BA/BS degree with 7 to 10 years of experience or Master’s degree with 5 to 7 years of experience in research and clinical study methodologies, or equivalent combination of education and experience is required.

Demonstrated experience overseeing study operations, participant recruitment and retention, regulatory compliance, and data management. Experience with Institutional Review Board (IRB) submissions and Good Clinical Practice (GCP) requirements. Proficiency with REDCap, Excel, and other clinical research databases and systems. Prior experience supervising, training, or mentoring research staff. Strong organizational, project management, problem-solving, and communication skills. Ability to manage multiple studies, priorities, and deadlines in a fast-paced research environment.

Skills

• Study workflow development and coordination
• Operational oversight of large-scale clinical research studies
• Protocol implementation and training
• REDCap CRF and database design, maintenance, and training
• Data quality monitoring and discrepancy resolution
• Regulatory document preparation and IRB submissions
• Staff supervision, performance management, onboarding, and professional development