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:
- 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.
- 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.
- 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.
- Site Contracts and Payment Coordination:
- Coordinate site contracts and payments, review invoices, and ensure reconciliation against clinical trial activities.
- 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.