Senior Clinical Research Associate

Company Description Regrow Biosciences Pvt Ltd is India's leading biotech company in regenerative medicine, focused on stem cell–based tissue and organ development. The company has built platform technologies for cell-based products and commercialized first three cell based products in India.

Role Description This is a full-time, Senior Clinical Research Associate role based in Mumbai. The Senior Clinical Research Associate will oversee and monitor clinical trials, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP). Responsibilities include coordination with apoointed CRO and heading the project. The role involves coordinating with investigators, clinical operations, data management, and regulatory teams to resolve issues and support trial progress. The Senior Clinical Research Associate will also contribute to protocol development, risk assessment, quality improvement initiatives, and leading the project from sponsor's end.

Qualifications

·Experience in Autoimmune and/or Oncology clinical trials (Preferred)

• Strong understanding of ICH-GCP, regulatory guidelines & clinical trial operations
• Candidates should possess strong skills in protocol review, protocol implementation, and protocol compliance.
• Candidates should possess skills relevant to Clinical Research Associates, including site monitoring, documentation, and stakeholder coordination.
• Candidates should possess experience with clinical trials, including study start-up, conduct, and close-out activities.
• Candidates should possess research skills, including data verification, analysis support, and interpretation of study findings.
• Candidates should possess capabilities in clinical operations, such as project coordination, timeline management, and cross-functional collaboration.
• Advanced knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Prior experience (typically 4–7 years) in clinical research, preferably in biotech, cell therapy, or regenerative medicine.
• Master's degree in life sciences, pharmacy, biotechnology, or a related field.
• Strong written and verbal communication skills, attention to detail, and ability to work in a structured, quality-driven environment.