Clinical Research Coordinator II - Nurse

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. 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. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.

Clinical Research Coordinator II - Nurse

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.

We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Responsibilities:

Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Able to manage an increased number of studies and/or more complex studies

Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies

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

If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.

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; contribute and implement ideas to improve site performance

Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality

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

Cooperates 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

Iterative Health Expectations

All employees are expected to:

Perform quality work within deadlines with or without direct supervision

Interact professionally with other employees, customers and suppliers

Work effectively as a team contributor on all assignments

Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations

Qualifications

Registered Nurse

Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty

Infusion experience

Minimum 3 years of clinical research experience

Ability to own issues and problem solve independently

Experience in phlebotomy preferred

Strong written and verbal communication skills

Ability to read, interpret, and apply clinic policies and research protocols

Abili…