Job Details

The Clinical Research Project Manager independently leads and manages clinical trials from study start-up through closeout, ensuring adherence to protocol requirements, institutional standards, and applicable regulatory guidelines. This role provides operational oversight of research activities, including feasibility planning, subject recruitment and retention, data and specimen management, and regulatory compliance. The manager may supervise and develop research staff, drives process improvements, and contributes to the development of standard operating procedures. Additionally, the position represents the organization in internal and external forums and serves as a subject matter expert, providing strategic guidance and consultation at the departmental or institutional level.

Job Description

Summary
The Clinical Research Project Manager independently leads and manages clinical trials from study start-up through closeout, ensuring adherence to protocol requirements, institutional standards, and applicable regulatory guidelines. This role provides operational oversight of research activities, including feasibility planning, subject recruitment and retention, data and specimen management, and regulatory compliance. The manager may supervise and develop research staff, drives process improvements, and contributes to the development of standard operating procedures. Additionally, the position represents the organization in internal and external forums and serves as a subject matter expert, providing strategic guidance and consultation at the departmental or institutional level.

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

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 metricsDirects 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.

Physical Demands
Lift and carry 40-50 lbs. Examples: Push/pull patients on bed, stretcher (requires 29 lbs. push force), lateral transfers up to 50 lbs. of the patient's weight. Frequent to continuous standing/walking. Patient transporters can walk 8-10 miles per shift. *Patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.

Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

1015 Walnut Street, Philadelphia, Pennsylvania, United States of America

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.