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Dr Reddy Labs

2 - 5 Years

4 - 9.6 Lacs per year

Hyderabad

M.pharm, Msc, Pharm.D, Life Sciences, Biology, Biotechnology, Biochemistry, or a diploma in Clinical Research.

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

The Clinical Research Associate (CRA) – Biologics role at Dr. Reddy’s Laboratories is a Clinical Research position, with a focus on managing and monitoring clinical trials, specifically for biologic products. This role includes a wide range of responsibilities that span the following areas:

Key Responsibilities:

  1. Study Start-up and Site Management:
    • Facilitate study start-up activities, including site qualification visits and ensuring the readiness of clinical investigational sites.
    • Ensure the availability of clinical trial material at sites and monitor site training needs.
  2. Clinical Trial Execution:
    • Oversee site activities, including the initiation of studies, training on study protocols, review of informed consent forms, and source data verification (SDV).
    • Manage Clinical Research Forms (CRFs), data entry, and resolve data queries from the sites.
  3. Investigational Product (IP) Management:
    • Monitor and ensure proper accountability, storage, and handling of investigational products.
    • Ensure the correct destruction or return of expired or unused IP.
  4. Site Contracts and Payment Coordination:
    • Coordinate site contracts and payments, review invoices, and ensure reconciliation against clinical trial activities.
  5. Regulatory Compliance:
    • Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and company SOPs throughout the study.
    • Assist with audits, inspections, and ensure the Trial Master File (TMF) is maintained in inspection-ready condition.

Ideal Candidate Qualifications:

  • Educational Requirements: A Master’s degree in Pharmacy, Life Sciences, Biology, Biotechnology, Biochemistry, or a diploma in Clinical Research.
  • Experience: 2-5 years of experience in clinical trial operations, with proficiency in using EDC systems for data management, and understanding of GCP and ICH guidelines.

Skills:

  • Technical: Knowledge of clinical trial operations, pharmacovigilance, and regulatory guidelines.
  • Behavioral: Strong communication, problem-solving, analytical, and project management skills.

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