Clinical Research Coordinator II- India

Overview

Coordinate and execute clinical research studies at Iterative Health India, supporting trial activities, participant experience and protocol compliance across assigned research sites.

What you'll do

• 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.
• 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.
• 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 and laboratory guidelines.
• 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 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.
• Ensure compliance with applicable regulations, institutional policies, privacy requirements, and Good Clinical Practice (ICH-GCP).
• Participate in ongoing training and quality improvement initiatives.
• Perform other duties as assigned.

What you'll need

• 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.
• 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.

Nice to have

• Experience supporting multiple clinical research sites or working in a centralized clinical operations environment.
• Familiarity with clinical research technologies, including CTMS, EDC, eSource, EMR/EHR, or similar systems.

Details

• Location: Mumbai, India.
• Compensation: ₹15 lakh – ₹25 lakh.
• Willingness to travel to other sites in India upon request.