What are the responsibilities and job description for the Clinical Research Coordinator position at Istios Health?
About Istios Health
Istios Health is a national, physician-led specialty network that strengthens specialty care delivery and expands access to clinical research where patients are treated every day. The company partners with independent specialists, healthcare facilities, and life sciences organizations to connect and scale clinical expertise, real-world evidence, telehealth, and research infrastructure in an integrated model.
Position Summary
We are seeking a Clinical Care Coordinator (CRC) to support the execution of our clinical research program within a rapidly expanding, innovative healthcare organization. This role is responsible for the day-to-day coordination of clinical trials at the site level, supporting study activities from start-up through closeout in accordance with study protocols and ICH-GCP guidelines. Responsibilities include coordinating participant visits, supporting recruitment and retention efforts, maintaining regulatory documentation, and performing delegated study tasks to ensure data quality, regulatory compliance, and adherence to study timelines. The ideal candidate has hands-on experience supporting clinical research studies, works effectively with investigators and site staff, and collaborates across clinical, regulatory, and operational teams to support high-quality research and patient care.
- Coordinate with the Principal Investigator, site teams, and Istios Health to ensure clinical research activities are conducted in compliance with study protocols, FDA regulations, ICH-GCP guidelines, and internal SOPs
- Support day-to-day execution of clinical trials, including participant pre-screening, recruitment, scheduling, and visit coordination
- Maintain and manage regulatory documentation, including protocols, investigator brochures, IRB materials, disclosures, CVs, and training records
- Conduct or support the informed consent process, including participant education and ongoing study communication
- Perform participant visits and protocol-required clinical procedures, including phlebotomy, vital signs, blood pressure, EKGs, centrifuge operation, and specimen processing, storage, and shipment
- Ensure accurate specimen accountability and coordinate courier pick-ups
- Enter study data into EDC systems, resolve queries, and maintain trial logs and participant charts using ALCOA-C documentation standards
- Track screening, enrollment, and study progress, ensuring timely communication with participants and study stakeholders
- Support monitoring visits and address findings in a timely manner
- Manage and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations
- Maintain adequate inventory of study supplies and coordinate participant reimbursement
- Prepare for and participate in site initiation visits (SIVs), investigator meetings (IMs), and required protocol and system trainings
- Set up, train, and maintain study-related technology as needed
- Communicate professionally with investigators, site staff, leadership, sponsors, CROs, vendors, and trial participants
- Adhere to all federal regulations and company policies related to patient privacy and protection of PHI
- Perform additional duties as assigned
Qualifications
- College degree (health sciences) preferred or significant relevant experience
- At least 2 years of CRC experience in a direct patient care role
- Knowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials
- Fluent in written and spoken English
- Ability to complete clinical procedures including phlebotomy, vitals, height, weight, ECGs
What We Offer
- Competitive compensation package
- Supportive and experienced leadership team with strong VC backing (BIP Ventures)