Clinical Research Lead

Thomas Jefferson University•Philadelphia, PA

1d•Onsite

About The Position

Works independently. Conducts clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. Trains research staff, supervises staff and oversees clinical trials from start-up to closeout. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, oversees research operation in a division or department and provides expert consulting at an institutional level.

Requirements

Minimum High School Diploma or equivalent
5 years of clinical research experience
3 years clinical research experience

Nice To Haves

Bachelor’s degree
Master’s Degree
CCRA - Certified Clinical Research Associate - Association of Clinical Research Professionals

Responsibilities

Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP).
Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP.
Prepares and submits all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely fashion.
Maintains accurate subject log, tracks expenses, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies.
Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP.
Organizes and maintains documentation of all patient data.
Designs electronic capture databases, if appropriate, and manage all the data collected.
May provide clerical and technical support to ensure adherence to research protocols and quality of information received.