Company Description medONE Pharma Solutions is a professionally managed Clinical Research Organization (CRO) with over two decades of experience in late-phase clinical research and real-world evidence generation in India. Since 2001, the organization has collaborated with leading pharmaceutical companies to design and deliver non-interventional and post-marketing studies across multiple therapeutic areas. medONE manages the full lifecycle of late-phase studies, backed by robust capabilities in Clinical Data Management, Biostatistics, Medical Writing, and Safety Oversight.

The company operates with a quality-first mindset aligned with global standards such as ICH E6 (R3) and has deep expertise in the Indian regulatory and site landscape. Its work emphasizes data integrity, risk-based oversight, and operational efficiency to generate reliable evidence that supports meaningful clinical and regulatory decisions.

Role Description The Clinical Research Associate (CRA) will support the planning, execution, and monitoring of late-phase clinical studies conducted by medONE in India. In this full-time, on-site role based in Gurugram, the CRA will perform routine site visits, oversee study conduct, ensure protocol adherence, and verify source data to maintain high-quality, analysis-ready datasets.

Responsibilities include coordinating with investigators and site staff,



managing essential documents, tracking study progress, and assisting in query resolution and data clarification. The role also involves ensuring compliance with applicable regulations, ICH-GCP guidelines, and internal SOPs, while contributing to risk-based oversight and continuous process improvement in real-world research settings.

Qualifications

- Candidates should possess solid skills in clinical research, including experience as Clinical Research Associates and involvement in Clinical Trials.
- Candidates should possess solid understanding of study Protocol requirements and practical experience in Clinical Operations.
- Candidates should possess demonstrated Research skills, including data review, documentation accuracy, and critical thinking.
- Relevant academic background such as a degree in life sciences, pharmacy, medicine, or related field.
- Knowledge of ICH-GCP, local regulatory requirements, and late-phase/post-marketing study practices.
- Strong communication and collaboration skills to work effectively with investigators, site staff, and internal teams.
- Attention to detail, organizational skills, and ability to manage multiple sites or studies in parallel.
- Prior experience in an Indian CRO or pharmaceutical environment is an advantage.

📌 Clinical Research Associate (Gurugram)
🏢 medONE, India
📍 Gurugram