Clinical Research Coordinator - Sr.

About the role

Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Runs portions of 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. May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups.

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.

Requirements

• High School Diploma/GED
• 5 years with High School Diploma/GED and SoCRA
• 6 years of clinical research experience
• 2 years with Bachelor’s degree and 2 years of clinical research experience
• 1 year with Master’s Degree and 1 year clinical research experience

Physical Demands

• Lift and carry 40–50 lbs (e.g., push/pull patients on bed, stretcher—requires 29 lbs push force; lateral transfers up to 50 lbs of patient’s weight).
• Frequent to continuous standing/walking; patient transporters may walk 8–10 miles per shift.
• Patient care providers may be required to kneel, bend, squat, and perform CPR.