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.

Application Link