Clinical Research Coordinator Senior - JCRI

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

Responsibilities

• 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, track expenses, submit 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 manages all the data collected.
• May provide clerical and technical support to ensure adherence to research protocols and quality of information received.

Qualifications

• Bachelor’s degree in a related field (e.g., biology, healthcare, pharmacy, etc.)
• Minimum of 2 years of experience in clinical research or related field
• Knowledge of Good Clinical Research Practice (GCP)
• Experience with regulatory submissions and IRB processes
• Strong organizational and project management skills
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite

Skills

• Good clinical research practices
• Data management
• Regulatory compliance
• Project management
• Communication and interpersonal skills

Benefits

Comprehensive benefits package including medical, dental, vision, life, and disability insurance, as well as retirement plans and tuition assistance.

Pay

Competitive salary commensurate with experience.

Schedule

Workday Day (United States of America) Worker Sub Type Regular Employee.