Clinical Research Coordinator I - Nurse - Richmond, VA

Iterative Health•Richmond, VA

About The Position

Iterative Health is a healthcare technology and services company that supports clinical research through a network of more than 100 sites across the US, Europe, India, and Australia. The Clinical Research Coordinator I – RN is an essential member of the site research team, supporting and coordinating the daily execution of clinical trials. The role manages patient interactions, protocol compliance, data integrity, and study operations in a fast-paced, protocol-driven environment, with opportunities for professional growth within Iterative Health’s site network. The coordinator administratively and clinically manages industry-sponsored trials; schedules and conducts participant visits; maintains study records and data; supports recruitment and monitoring; and performs nursing procedures required by study protocols and site policies. The role adheres to research SOPs, Good Clinical Practice guidelines, FDA requirements, and participant-protection regulations, while communicating with participants, investigators, sponsors, CROs, and site management.

Requirements

Active Registered Nurse (RN) license.
Solid nursing background, with a concentration in GI specialty or willingness to develop advanced GI knowledge.
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.
Strong organizational skills and ability to manage multiple priorities and meet deadlines.
Ability to work independently and collaboratively in a fast-paced environment.

Nice To Haves

One to two years of clinical research experience is strongly 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.

Responsibilities

Administratively and clinically manage industry-sponsored clinical trials, including problem-solving, communication, and protocol management.
Schedule patient research visits and procedures in accordance with protocol requirements.
Enter study and subject-specific information into the CTMS regularly.
Complete and maintain study documentation, including consent forms, source documentation, progress notes, case report forms, and investigational accountability forms.
Maintain case report forms in accordance with FDA guidelines and review them against patient medical records for completeness and accuracy.
Schedule and prepare for monitor visits.
Maintain onsite inventory of study equipment and supplies.
Lead patient recruitment activities, including chart reviews, protocol discussions, and verification of informed consent documentation.
Conduct patient visits as outlined in study protocols and serve as the primary point of contact for study participants throughout each study.
Dispense study medication, collect vital signs, and perform ECGs per protocol.
Perform blood draws and process and ship specimens according to study protocols and IATA regulations.
As assigned, place IVs; administer IV medications, fluids, and intramuscular or subcutaneous injections; monitor patients during infusions; and discharge patients in accordance with protocols and site policies.
Follow research SOPs, Good Clinical Practice guidelines, and study protocols.
Assist with routine data verification and quality control to ensure data integrity and consistency with study protocols.
Ensure safety data is reviewed by the PI in a timely manner.
Cooperate with site compliance and monitoring efforts concerning access to, use of, and disclosure of PHI, and report noncompliance to the appropriate compliance office.
Help protect the rights and welfare of human research participants in accordance with federal regulations.
Maintain communication with the CRO, sponsor, research participants, Site Manager, and PI throughout each study.
Communicate study status and results to management.
Perform other job-related duties as requested.