healthcare
Posted 20 hours agoClinical Research Coordinator I - India
Mumbai, IndiaOn-site
Responsibilities
- Coordinate and execute clinical trial activities in accordance with study protocols, ICH-GCP guidelines, applicable CDSCO regulations, ICMR ethical guidelines, and site SOPs.
- Support participant recruitment, pre-screening, enrollment, scheduling, retention, and follow-up activities.
- Coordinate and conduct protocol-required participant visits while ensuring participant safety and protocol compliance.
- Obtain and document informed consent in accordance with study
- Maintain accurate, complete, and timely source documentation, regulatory documentation, CTMS updates, and electronic Case Report Forms (eCRFs).
- Coordinate investigational product accountability and study supply management.
- Collaborate with investigators, sponsors, CROs, central laboratories, and internal teams to ensure successful study execution.
- Support study startup, site activation, document collection, and ongoing maintenance of essential study documentation across assigned research sites.
- Review study documentation for completeness, accuracy, and protocol compliance while supporting data quality and inspection readiness.
- Prepare for and support sponsor monitoring visits, audits, and regulatory inspections.
- Maintain study regulatory files and essential documents throughout the study lifecycle.
- Perform other duties as assigned.
Requirements
- 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.
- Bachelor's or Master's degree in Life Sciences, Pharmacy (B.Pharm/PharmD), Nursing, Biotechnology, Allied Health Sciences, or a related scientific discipline.
- Working knowledge of ICH-GCP guidelines and Indian clinical research regulations. •
- Experience supporting multiple clinical research sites or working in a centralized clinical operations environment is preferred.
- Strong understanding of clinical trial documentation and research workflows.
- Ability to manage multiple studies and competing priorities in a fast-paced environment.
- Strong interpersonal skills with the ability to build relationships with participants, investigators, sponsors, and internal stakeholders.
- Proficiency with Microsoft Office applications.
- Familiarity with clinical research technologies, including CTMS, EDC, eSource, EMR/EHR, or similar systems preferred Physical Requirements
- Ability to sit, stand, and move throughout clinical and office environments for extended periods of time
- Ability to lift and move up to 10 kilograms (22 pounds) as needed
Experience
- 1–3 years of clinical research, healthcare, or hospital experience.
Benefits
- Compensation: ₹12 lakh- ₹17 lakh
Contact
- experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
- 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.
- Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
- As a Clinical Research Coordinator I (CRC I) at Iterative Health India, you will play an integral role in the successful execution of clinical trials while ensuring an exceptional participant experience.
- You will support the day-to-day coordination of research studies by partnering with investigators, sponsors, CROs, and cross-functional teams to deliver high-quality clinical research that advances innovative therapies.
- This position requires strong organizational skills, attention to detail, and a commitment to participant safety, protocol compliance, and research excellence.
- Travel: Willingness to travel to other sites in India upon request.
- Provide centralized operational support across multiple research sites, coordinating study documentation, participant scheduling, data management activities, and operational workflows while partnering with local site teams to ensure consistent study execution and regulatory compliance.
- Process, prepare, and ship laboratory specimens according to protocol
- Enter study data into EDC systems and assist with timely resolution of data queries.