Clinical Research Project Mgr

Job Duties

• Independently oversees and executes all phases of clinical trials from start-up to closeout, including feasibility assessments, protocol coordination (screening, recruiting, enrolling, consenting), data and biological specimen management, and preparation for monitoring visits, ensuring compliance with Good Clinical Practice (GCP) and all applicable regulations.
• May supervise, train, and mentor research staff, ensuring proper conduct of clinical trials, adherence to protocols, and consistent application of regulatory and institutional standards.
• Prepares, reviews, and submits regulatory and IRB documentation in a timely manner, maintains accurate study records and subject logs, tracks study finances, and performs quality control assessments to ensure integrity, accuracy, and audit readiness of clinical trial data.
• Leads or supports research operations within a division or department, contributes to and implements standard operating procedures, participates in leadership initiatives, and represents the organization internally and externally while providing expert consultation on clinical research processes and compliance.

Minimum Qualifications

• Bachelor’s Degree
• Master’s Degree
• 5 years clinical research experience and 3 years clinical research experience and 2 years lead/Project Management experience
• SoCRA Certification

Additional Qualifications

• Oversees the completion of all necessary regulatory preparations prior to sponsor visits (e.g., monitoring and auditing visits, site activation visits).
• Ensures that any regulatory action items resulting from a sponsor visit are completed in a timely and efficient manner.
• Ensures that regulatory document version control is maintained, and that all clinical trial documentation is “audit ready" at all times.
• Reviews all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Creates and establishes a process for ensuring quality submissions to the TJU IRB and the FDA.
• Interacts with Principal Investigators (PIs), Jefferson Clinical Research Institute (JCRI), Office of Research Administration (ORA), Office of Human Research (OHR), hospital staff, etc. to ensure efficient processing of trials.
• Works with the Team to ensure all communications regarding regulatory documentation that are provided by sponsors are distributed and received by the regulatory staff in a timely manner.
• Actively participates and represents the departments in feasibility assessments.
• Manages all aspects of clinical research regulation from protocol inception to completion; and tracking quality metrics
• Directs regulatory documentation and workflow for clinical trials through the use of project management techniques and tools (e.g., spreadsheets, progress reports, priority setting).
• Maintains an efficient organizational structure for processing all clinical protocols assigned to the Team, which includes NCI cooperative group protocols, industry-sponsored trials, and investigator-initiated studies including multi-sites.
• Performs other duties as assigned.