Clinical Research Project Manager

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

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.

Education

- Required Bachelor’s Degree Master’s Degree Experience - Required 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 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 Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Albert Einstein Medical Center Primary Location Address 5501 Old York Road, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value

Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrows professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research

Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200 undergraduate and graduate programs to more than 8,300 students

Jefferson Health , nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region

Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years

Jefferson is committed to providing equal educa­tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.

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

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