Job Details

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.

Job Description

Essential Functions

• Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
• 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.

Minimum Education and Experience Requirements:

• Bachelor’s degree and 5 years of clinical research experience or master’s degree and 3-year clinical research experience.

Minimum Certifications, Registration or License Requirements:

• SoCRA Certification preferred

Work Shift

Workday Day (United States of America)