Iterative Health
Clinical Research Coordinator II - New Albany, IN
New Albany, IN · Mid · Full-time
Sponsorship not specifiedDetected 5 days ago
HIPAAClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationProblem Solving
About the role
- 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.
Responsibilities
- Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Manage a full schedule of complex study visits and corresponding tasks with minimal direction.
- 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, with accountability for achieving enrollment goals
- Dispense study medication, collect vital signs and perform ECGs
- Perform blood draws, process and ship specimens per study protocol and IATA regulations
- 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.
- Maintain high quality data entry within established timelines
- 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.
- Contribute to status updates to management; contribute and implement ideas to improve site performance
- Perform quality work within deadlines with or without direct supervision
- Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services.
Requirements
- Minimum 3 years of clinical research experience
- Ability to read, interpret, and apply clinic policies and research protocols
- Ability to use standard office software
- Must be able to lift up to 25 pounds
- Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
- IBD experience is a must
- Ability to own issues and problem solve independently
- Strong written and verbal communication skils
Nice to have
- Experience in phlebotomy preferred
Benefits
- Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
- 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.
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, central Iterative Health team, and PI throughout the study.
- 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
Company info
- Interact professionally with other employees, customers and suppliers
- We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II).
Visa & Work Authorization
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, central Iterative Health team, and PI throughout the study
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This listing is sourced directly from Iterative Health's careers page and normalized into a canonical job model.