Clinical Research Coordinator I - Nurse - Richmond, VA

Where You'll Drive Impact

• Administratively and clinically manage industry-sponsored clinical trials, including problem-solving, communication, and protocol management.
• Schedule all patient research visits and procedures in accordance with protocol requirements.
• Ensure relevant study and subject-specific information is entered into the CTMS on a regular basis.
• Complete and maintain study documentation including consent forms, source documentation, progress notes, case report forms, and investigational accountability forms.
• Complete and maintain case report forms per FDA guidelines, reviewing them against patient medical records for completeness and accuracy.
• Schedule and prepare for monitor visits.
• Maintain inventory of study equipment and supplies onsite at all times.
• Lead patient recruitment activities including chart reviews, protocol discussions with patients, and verification of informed consent documentation.
• Conduct patient visits as outlined within each study protocol.
• Act as the primary point of contact for study participants throughout the course of the study.
• Dispense study medication, collect vital signs, and perform ECGs per protocol.
• Perform blood draws; process and ship specimens per study protocol and IATA regulations.
• As assigned: place IVs, administer IV medications and fluids, give intramuscular and subcutaneous injections, monitor patients during infusion, and discharge patients in accordance with protocol and site policies.
• Adhere to Research SOPs, Good Clinical Practice (GCP) guidelines, and study protocols at all times.
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocols.
• Ensure all safety data is reviewed by the PI in a timely manner.
• Cooperate with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI; report instances of noncompliance to the appropriate compliance office.
• Assist the study team in protecting the rights and welfare of all human research participants in accordance with federal regulations.
• Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, and PI throughout the course of each study.
• Actively participate in communication of status and results to management.
• Perform job related duties as requested

What You Bring to the Team

• Active Registered Nurse (RN) license required.
• 1-2 years of clinical research experience strongly preferred.
• Solid nursing background with a concentration in, or willingness to develop advanced knowledge of, GI specialty.
• Ability to execute research tasks with guidance from experienced staff, PIs, and management.
• Strong written and verbal communication skills.
• Ability to read, interpret, and apply clinic policies and research protocols.
• Proficiency in standard office software and CTMS platforms.
• Highly organized with the ability to manage multiple priorities and meet deadlines.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications

• Prior GI or hepatology clinical research experience.
• Familiarity with GCP guidelines and FDA regulations governing clinical research.
• Experience with CTMS, EDC, or eTMF platforms.
• ACRP or SOCRA certification (CCRC or CCRP), or active pursuit of certification.

Additional information

At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact.