Clinical Research Lead

Jefferson Health Plans • Philadelphia, PA

3d • 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

• High School Diploma/GED Minimum High School Diploma or equivalent
• 5 years Bachelor’s degree and 5 years of clinical research experience
• 3 years Master’s Degree and 3 year clinical research experience.
• 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.

Benefits

• medical (including prescription)
• supplemental insurance
• dental
• vision
• life and AD&D insurance
• short- and long-term disability
• flexible spending accounts
• retirement plans
• tuition assistance
• voluntary benefits
• tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level