Clinical Research Coordinator I

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.
• 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.
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
• Schedule and prepare for monitor visits.
• 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

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred.
• Minimum 1-2 years of clinical research experience.
• Able to execute on research tasks with guidance from more experienced staff, PIs, and management.
• Strong written and verbal communication skills.
• Ability to read, interpret, and apply clinic policies and research protocols.
• Ability to use standard office software.
• Must be able to lift up to 25 pounds.