Company Description Concept Clinical Service is a Research Management Organization dedicated to supporting successful clinical trials for the pharmaceutical, biotechnology, and medical device industries. The organization focuses on rigorous protocol adherence, comprehensive documentation, high-quality data, and compliance with ICH-GCP and other regulatory standards.

It provides end-to-end services including study design, regulatory consulting, site and patient management, monitoring, pharmacovigilance, data management, biostatistics, and medical writing.

Concept Clinical

Service aims to be recognized for exceptional service, responsiveness, and tailored solutions, with solid expertise and networks in rare diseases across India. Team members collaborate with sponsors and sites to deliver efficient and ethically sound clinical research outcomes.

Role Description The Clinical Research Coordinator role is a full-time, on-site position based in Surat. The coordinator will manage day-to-day clinical trial activities, including screening and enrolling participants, obtaining informed consent, and maintaining accurate and timely study documentation.

Responsibilities include coordinating visits, ensuring adherence to study protocols and regulatory requirements, handling data entry and query resolution,



and supporting safety reporting and compliance with ICH-GCP guidelines. The role involves close collaboration with investigators, study nurses, sponsors, and monitors, facilitating communication, preparing for monitoring visits and audits, and maintaining trial master files. The coordinator will also assist with patient follow-up, site logistics, and continuous quality improvement in study conduct.

Qualifications

- Strong understanding of clinical research processes, including Research and Clinical Trials
- Hands-on Clinical Research Experience in coordinating or supporting clinical studies
- Knowledge of Protocol requirements and ability to ensure protocol adherence
- Experience with Informed Consent procedures and participant communication
- Bachelor’s or master’s degree in life sciences, pharmacy, nursing, or a related field
- Familiarity with ICH-GCP guidelines and relevant regulatory standards
- Excellent organizational, documentation, and time-management skills
- Strong written and verbal communication skills and ability to work in a multidisciplinary team
- Proficiency with basic office software and electronic data capture systems
- Prior experience in rare disease studies or site management is an advantage

📌 Clinical Research Coordinator (Surat)
🏢 Concept Clinical Service
📍 Surat