Infusion RN - Rochester, NY

Iterative Health•Rochester, NY

About The Position

The Infusion RN is an essential member of Iterative Health’s site research team, supporting and coordinating the daily execution of clinical trials. The role combines nursing care and clinical research responsibilities, including patient interactions, protocol compliance, data integrity, and study operations. The RN works with guidance from experienced staff, principal investigators, and management in a fast-paced, protocol-driven environment. The position is based in Rochester, New York.

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 with standard office software and CTMS platforms.
Strong organization 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 according to protocol requirements.
Regularly enter relevant study and subject-specific information into the CTMS.
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 with patients, 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 according to protocol.
Draw blood and process and ship specimens in accordance with study protocols and IATA regulations.
As assigned, place IVs, administer IV medications and fluids, give intramuscular and subcutaneous injections, monitor patients during infusions, and discharge patients according to protocol and site policies.
Adhere to 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; report noncompliance to the appropriate compliance office.
Help protect the rights and welfare of human research participants in accordance with federal regulations.
Maintain ongoing communication with CROs, sponsors, research participants, the Site Manager, and the PI throughout each study.
Communicate study status and results to management.
Perform other job-related duties as requested.