Clinical Research Project Mgr

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

• Bachelors Degree
• Masters 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 that regulatory document version control is maintained and that all clinical trial documentation is audit ready at all all regulatory submission materials to ensure timeliness accuracy comprehensiveness or compliance with regulatory 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 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 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 patients 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

1025 Walnut Street 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 65000 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 8300 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 diemcolleagues adjunct faculty and Jeff Temps) have access to medical (including prescription) insurance.

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