Clinical Research Coordinator I - India at Iterative Health

<div class="content-intro"><p><span style="font-size: 10pt;">Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.</span></p> <p><span style="font-size: 10pt;">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. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.</span></p> <p>&nbsp;</p></div><p><span style="font-size: 10pt;">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.</span></p> <p><span style="font-size: 10pt;">This position requires strong organizational skills, attention to detail, and a commitment to participant safety, protocol compliance, and research excellence.</span></p> <p><span style="font-size: 10pt;"><strong>Location:</strong> Mumbai, India</span></p> <p><span style="font-size: 10pt;"><strong>Compensation:</strong> ₹12 lakh- ₹17 lakh</span></p> <p><span style="font-size: 10pt;"><strong>Travel:</strong> </span><span style="font-size: 10pt;">Willingness to travel to other sites in India upon request.&nbsp;</span></p> <p><span style="font-size: 10pt;"></span></p> <h2><span style="font-size: 10pt;">Where You’ll Drive Impact</span></h2> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Coordinate and execute clinical trial activities in accordance with study protocols, ICH-GCP guidelines, applicable CDSCO regulations, ICMR ethical guidelines, and site SOPs.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Support participant recruitment, pre-screening, enrollment, scheduling, retention, and follow-up activities.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">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.&nbsp;&nbsp;</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Coordinate and conduct protocol-required participant visits while ensuring participant safety and protocol compliance.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Obtain and document informed consent in accordance with study requirements and institutional policies.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Process, prepare, and ship laboratory specimens according to protocol requirements and laboratory guidelines.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Maintain accurate, complete, and timely source documentation, regulatory documentation, CTMS updates, and electronic Case Report Forms (eCRFs).</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Enter study data into EDC systems and assist with timely resolution of data queries.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Coordinate investigational product accountability and study supply management.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Serve as the primary point of contact for study participants throughout study participation.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Collaborate with investigators, sponsors, CROs, central laboratories, and internal teams to ensure successful study execution.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Support study startup, site activation, document collection, and ongoing maintenance of essential study documentation across assigned research sites.&nbsp;</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Review study documentation for completeness, accuracy, and protocol compliance while supporting data quality and inspection readiness.&nbsp;</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Prepare for and support sponsor monitoring visits, audits, and regulatory inspections.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Maintain study regulatory files and essential documents throughout the study lifecycle.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ensure compliance with applicable regulations, institutional policies, privacy requirements, and Good Clinical Practice (ICH-GCP).</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participate in ongoing training and quality improvement initiatives.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Willingness to travel to other sites in India upon request.&nbsp;</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Perform other duties as assigned.</span></li> </ul> <p>&nbsp;</p> <p><span style="font-size: 10pt;">What You Bring to the Team</span></p> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Bachelor's or Master's degree in Life Sciences, Pharmacy (B.Pharm/PharmD), Nursing, Biotechnology, Allied Health Sciences, or a related scientific discipline.&nbsp;</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">1–3 years of clinical research, healthcare, or hospital experience.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Working knowledge of ICH-GCP guidelines and Indian clinical research regulations.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience supporting multiple clinical research sites or working in a centralized clinical operations environment is preferred.&nbsp;</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong understanding of clinical trial documentation and research workflows.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Excellent organizational skills with strong attention to detail.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to manage multiple studies and competing priorities in a fast-paced environment.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Effective verbal and written communication skills in English.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong interpersonal skills with the ability to build relationships with participants, investigators, sponsors, and internal stakeholders.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Proficiency with Microsoft Office applications.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Familiarity with clinical research technologies, including CTMS, EDC, eSource, EMR/EHR, or similar systems preferred&nbsp;</span></li> </ul> <p>&nbsp;</p> <h2><span style="font-size: 10pt;">Physical Requirements</span></h2> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to sit, stand, and move throughout clinical and office environments for extended periods of time</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to lift and move up to 10 kilograms (22 pounds) as needed</span></li> </ul> <p><br><br><br></p><div class="content-conclusion"><p><span style="font-size: 10pt;">At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact [email protected].</span></p></div>