Clinical Research Coordinator I - Nurse

Responsibilities

• Adminstratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation.
• Schedule all patient research visits and procedures consistent with protocol requirements.
• Conduct patient visits as outlined within each study protocol.
• Dispense study medication, collect vital signs and perform ECGs.
• Perform blood draws, process and ship specimens per study protocol and IATA regulations.
• If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
• Act as point of contact for study participants.
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols.
• Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study.
• Ensure all safety data is reviewed by the PI in a timely manner.
• Maintain inventory of study equipment and supplies onsite at all times.
• Participate actively in communication of status and results to management.
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations.
• Cooperate with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance.
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy.

Qualifications

• Bachelor's degree in Nursing or related field.
• Minimum of 2 years of experience in clinical research coordination or related field.
• Current Registered Nurse (RN) license in good standing.
• Experience with electronic health records (EHR) systems.
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of Good Clinical Practices (GCP).