Clinical Research Coordinator I - India

Iterative-Health; Mumbai; On-site; INR 400,000 - 700,000; Full time

Job summary

Iterative Health India is seeking a Clinical Research Coordinator I to support the day-to-day coordination of clinical trials across India. You will partner with investigators, sponsors, CROs and cross-functional teams to deliver high-quality research in line with ICH-GCP and CDSCO requirements.

The role emphasizes participant safety, protocol compliance, meticulous data management, and timely study documentation, with travel to other Indian sites as needed.

Qualifications

• Bachelor's or Master's in Life Sciences, Pharmacy, Nursing, Biotechnology, or related field.
• 1–3 years of clinical research, healthcare, or hospital experience.
• Working knowledge of ICH-GCP guidelines and Indian regulations.
• Experience supporting multiple clinical research sites or centralized operations preferred.

Responsibilities

• Coordinate and execute clinical trial activities across sites per protocol and ICH-GCP.
• Support recruitment, screening, enrollment, and follow-up activities.
• Manage study documentation, data management, and regulatory compliance.
• Prepare for sponsor monitoring visits and regulatory inspections.
• Maintain regulatory files throughout study lifecycle.

Skills

Organizational skills

English communication

Interpersonal skills

Attention to detail

Multitasking

Microsoft Office

Education

Life sciences/related degree

Nursing/Pharmacy/Biotechnology or allied health qualification

Tools

CTMS

EDC

eSource

EMR/EHR

Microsoft Excel

Job description

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. 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.

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.

Where You’ll Drive Impact

• 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 to ensure consistent study execution and regulatory compliance.
• 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.
• Willingness to travel to other sites in India upon request.
• Perform other duties as assigned.

What You Bring to the Team

• 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.
• 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.
• 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.
• 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

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 [e-mail].