Senior Clinical Research Associate
4 weeks ago
Job Title: Senior Clinical Research Associate
About the Role:
We are seeking a highly skilled Senior Clinical Research Associate to join our team at Syngene. As a Senior Clinical Research Associate, you will be responsible for site management, monitoring visits, and ensuring the quality and integrity of studies conducted at site level.
Key Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work, Standard Operating Procedures, and Good Clinical Practice (GCP) Guidelines and Regulations.
- Responsible for site management for assigned protocols, sites, and therapeutic areas.
- Complete Standard Operating Procedure training, therapeutic area training, protocol training, and any relevant training required to perform job duties.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and activities.
- Ensure the quality and integrity of studies conducted at site level in accordance with protocol and applicable regulations.
- Manage the progress and performance of assigned study sites by tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentations.
- Provide assistance to the Clinical Project Manager with design of study tools, documents, and processes.
- Timely submission of timesheets for project-specific and other tasks.
Requirements:
- M. Sc/M. Pharm/Pharm D, BAMS, BDS, MDS & BHMS/Any life science degree.
- 3-9 years of experience in clinical research.
- Good communication skills and ability to work in a dynamic environment.
Equal Opportunity Employer:
Syngene is an equal opportunity employer and welcomes applications from diverse candidates.
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