Clinical Research Lead

Works independently to conduct 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. Ensures all study procedures are conducted according to the protocol and applicable regulations.

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 logs, tracks expenses, and submits appropriate documentation to the Grant Administrator monthly for payment due on all studies.
• Performs regular quality control assessments to ensure clinical trial data is collected and stored per GCP.
• Organizes and maintains documentation of all patient data.
• Designs electronic capture databases, if appropriate, and manages all collected data.
• May provide clerical and technical support to ensure adherence to research protocols and quality of information received.
• Develops and/or contributes to standard operating procedures and processes.
• Attends and engages in leadership meetings, represents the institution internally and externally, oversees research operations in a division or department, and provides expert consulting at an institutional level.

Requirements

• High School Diploma or GED or Bachelor’s degree and 5 years of clinical research experience or Master’s Degree and 3 years of clinical research experience.
• CCRA (Certified Clinical Research Associate) certification from the Association of Clinical Research Professionals preferred.

Physical Demands

• Lift and carry up to 25 lbs.
• Frequent sitting, standing, and keyboard use.
• May require kneeling, bending, squatting, and performing CPR (role-specific).

Benefits

• Comprehensive benefits package for full-time and part-time colleagues, including medical (including prescription), dental, vision, life, and AD&D insurance.
• Short- and long-term disability coverage.
• Flexible spending accounts.
• Retirement plans.
• Tuition assistance and discounts at Thomas Jefferson University after one year of full-time service or two years of part-time service.
• Voluntary benefits, including group insurance rates and discounts.
• All colleagues, including those working less than part-time (per diem, adjunct faculty, and temps), have access to medical (including prescription) insurance.

Schedule

Workday Day shift (United States of America).