Duties and Responsibilities

• Administratively and clinically manage multiple clinical trials, simultaneously.
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols.
• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
• Assist the Principal Investigator (PI) in identifying prospective candidates for upcoming clinical trials.
• Review and verify all relevant source documents with the PI to confirm patients' eligibility.
• Assist Clinical Research Supervisor with regulatory files or work directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Review study protocol and follow-up procedures with potential study patients
• Provide patients education on an ongoing basis throughout their participation in the clinical trial.
• Complete visit procedures including, but not limited to, obtaining vital signs, performing ECGs, and collecting blood samples for processing and shipment to the appropriate lab facility.
• Complete and maintain case report forms (CRF) per FDA guidelines, GCP, and protocol requirements. Review CRF against the patient's record for completeness and accuracy.
• Ensure that all data and/or all queries are entered and addressed, respectively in a timely manner in the appropriate electronic data capture (EDC) database.

Qualifications

• Licensed Practical Nurse LPN (Required)
• 1-2 years of Clinical Research Coordinator experience (Preferred)