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Salary: INR 1,500,000 - 2,500,000 / annual
Iterative Health is a healthcare technology and services company accelerating clinical research across gastrointestinal, hepatology, obesity, and cardiology. The company operates a network of 100+ research sites across the US, Europe, India, and Australia, combining clinical trial expertise with AI to connect sponsors with high-performing research teams.
As a Clinical Research Coordinator II in Mumbai, you will play an integral role in the successful execution of clinical trials while ensuring an exceptional participant experience. You will support 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.
Key responsibilities include:
- Coordinate and execute clinical trial activities in accordance with study protocols, ICH-GCP guidelines, CDSCO regulations, ICMR ethical guidelines, and site SOPs
- Support participant recruitment, pre-screening, enrollment, scheduling, retention, and follow-up activities
- Provide centralized operational support across multiple research sites, coordinating study documentation, participant scheduling, data management, and operational workflows
- Coordinate and conduct protocol-required participant visits while ensuring participant safety and protocol compliance
- Obtain and document informed consent in accordance with study requirements and institutional policies
- Process, prepare, and ship laboratory specimens according to protocol requirements
- Maintain accurate, complete, and timely source documentation, regulatory documentation, CTMS updates, and electronic Case Report Forms (eCRFs)
- Enter study data into EDC systems and assist with timely resolution of data queries
- Coordinate investigational product accountability and study supply management
- Serve as the primary point of contact for study participants throughout study participation
- Collaborate with investigators, sponsors, CROs, central laboratories, and internal teams
- Support study startup, site activation, document collection, and ongoing maintenance of essential study documentation
- Review study documentation for completeness, accuracy, and protocol compliance
- Prepare for and support sponsor monitoring visits, audits, and regulatory inspections
- Maintain study regulatory files and essential documents throughout the study lifecycle
- Ensure compliance with applicable regulations, institutional policies, privacy requirements, and Good Clinical Practice (ICH-GCP)
- Participate in ongoing training and quality improvement initiatives
- Willingness to travel to other sites in India upon request
Requirements:
- Bachelor's or Master's degree in Life Sciences, Pharmacy (B.Pharm/PharmD), Nursing, Biotechnology, Allied Health Sciences, or a related scientific discipline
- 1–3 years of clinical research, healthcare, or hospital experience
- Working knowledge of ICH-GCP guidelines and Indian clinical research regulations
- Strong understanding of clinical trial documentation and research workflows
- Excellent organizational skills with strong attention to detail
- Ability to manage multiple studies and competing priorities in a fast-paced environment
- Effective verbal and written communication skills in English
- Strong interpersonal skills with the ability to build relationships with participants, investigators, sponsors, and internal stakeholders
- Proficiency with Microsoft Office applications
- Experience supporting multiple clinical research sites or working in a centralized clinical operations environment is preferred
- Familiarity with clinical research technologies, including CTMS, EDC, eSource, EMR/EHR, or similar systems is preferred
Physical Requirements:
- Ability to sit, stand, and move throughout clinical and office environments for extended periods
- Ability to lift and move up to 10 kilograms (22 pounds) as needed
