Senior Research Associate

5 days ago

Bengaluru, Karnataka, India beBeeResearch Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Research Professional

Job Summary:

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our organization in Bangalore. The successful candidate will be responsible for performing site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work, standard operating procedures, and all applicable good clinical practice guidelines and regulations.

Key Responsibilities:
  • Perform site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work, SOPs, and GCP guidelines and regulations.
  • Responsible for site management for the assigned protocols, sites, and therapeutic areas.
  • Complete appropriate SOP 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.
  • Investigate and discuss quality issues with the clinical project manager for resolution and implementation of corrective action and preventive action.
  • Manage the progress and performance of the assigned study sites by following activities but not limited to tracking regulatory and ethics committee submissions and approvals, subject recruitment, case report form 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.
Requirements:
  • M.Sc., M.Pharm., Pharm.D., BAMS, BDS, MDS, or BHMS in life sciences.
  • 3-9 years of experience in clinical research operations.
  • Good communication skills and ability to work effectively in a dynamic environment.
  • Ability to meet tight deadlines and prioritize workloads.
  • Ability to develop new ideas and creative solutions.
  • Focused employee with strong organizational skills.

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