healthcare
Posted 12 hours agoClinical Research Coordinator I - RN
Tyler, United StatesOn-site
Responsibilities
- 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.
- Perform blood draws; process and ship specimens per study protocol and IATA regulations.
- 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.
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, and PI throughout the course of each study.
- Perform job related duties as requested
Requirements
- By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
- The ideal candidate brings clinical research experience, a patient-first mindset, strong attention to detail, and the ability to thrive in a fast-paced, protocol-driven environment.
- Active Registered Nurse (RN) license required.
- 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.
- 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
- 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.
Experience
- 1–2 years of clinical research experience strongly preferred .
Contact
- experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
- Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.
- We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
- Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
- A Clinical Research Coordinator I – RN at Iterative Health is an essential member of the site research team, supporting, facilitating, and coordinating the daily execution of clinical trials across our network.
- This role is at the heart of every study — managing patient interactions, ensuring protocol compliance, maintaining data integrity, and keeping the operational machinery of clinical research running smoothly.
- This role provides a strong foundation for success while offering a clear path for professional growth within Iterative Health's expanding site network.
- Administratively and clinically manage industry-sponsored clinical trials, including problem-solving, communication, and protocol management.
- 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.
- 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.