The Lead Clinical Research Coordinator manages the daily operations of clinical trials. The CRC will screen, enroll, and follow study subjects for clinical trials, ensuring protocol compliance and close monitoring throughout the subject's participation in the study. Manage and Lead junior level CRC.
RESPONSIBILITIES
• Conducting Clinical Trials
o Review the protocol, study design, inclusion/exclusion criteria, schedule of events, and the informed consent form to ensure understanding.
o Develop and implement strategies for subject recruitment and ongoing communications with physicians, research staff, and office staff.
o Prepare study charts, binders, and supplies for upcoming subject visit.
o Ensure maintenance and calibration of study equipment.
o Ensure that all study supplies are stocked and check expiration dates.
• Enrolling Study Subjects and Conducting Follow Up Visits/Procedures
o Review, verify, and record relevant documentation in the subjects medical record needed to confirm study eligibility.
o Ensure the current approved informed consent is signed before subjects are screened and enrolled.
o Perform delegated protocol specific tasks as assigned
o Ensure that the randomization procedures are followed and documented per protocol guidelines.
o Document all study procedures, adverse events, and changes to concomitant medications per protocol throughout the duration of the subjects participation in the trial.
o Communicate with PI and nuclear technologists to ensure timely and accurate study drug administration, scans and PK’s when applicable
o Report any Serious Adverse Events and/or Protocol Deviations to the PI and Central Research Office as soon as possible upon knowledge of the event.
o Maintain accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, accountability logs, subject logs, and study-related communications.
o Resolve any action items/findings in a timely manor after each monitoring visit is completed.
EDUCTION & EXPEREINCE
• Management/Leadership experience
• Minimum of five (5) years of clinical research experience.
• Maintained ACRP or SOCRA certification, preferred.
• Knowledge of FDA/ICH guidelines and Good Clinical Practice (GCP).
• Excellent communication and organizational skills.
PHYSICAL REQUIREMENTS
Prolonged periods of sitting at a desk working on a computer, capacity for prolonged standing, walking, and sitting during meetings or patient visits.
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