Dr. Reddy’s Laboratories has announced a new Clinical Research Associate job in Hyderabad within its Biologics – Clinical Operations team. This opportunity is suitable for clinical research professionals with experience in clinical trial operations, site management, study start-up, monitoring, SDV, EDC systems, ICH-GCP compliance and Trial Master File management.

Candidates with a Master’s degree in Pharmacy, Life Sciences, Biology, Biotechnology or Biochemistry, or a Diploma in Clinical Research, along with relevant research experience, can apply for this Dr Reddy’s Clinical Research Associate vacancy.

The selected professional will support clinical investigational sites throughout the study lifecycle, including site qualification, study initiation, monitoring, investigational product accountability, site payments, vendor coordination and inspection readiness.

Dr Reddy’s Clinical Research Associate Job Overview

About the Clinical Research Associate Role

The Clinical Research Associate at Dr Reddy’s will be involved in end-to-end management of clinical investigational sites.

The position includes study start-up activities, site qualification and initiation, site monitoring, source data verification, CRF and query review, investigational product accountability, vendor coordination, site contracts and payments, TMF maintenance and compliance with protocol, SOPs, ICH-GCP and regulatory requirements.

The CRA will also work closely with Data Management, Safety, Medical and other internal project teams to resolve study-related issues and maintain trial quality.

Key Responsibilities

Study Start-Up and Site Qualification

The Clinical Research Associate will:

• Facilitate clinical study start-up activities at investigational sites.
• Conduct feasibility assessments and review site feasibility data.
• Perform site qualification visits.
• Evaluate investigator qualifications and adequacy of site staff.
• Assess site facilities and potential patient populations.
• Collect essential documents required for regulatory and Ethics Committee submissions.
• Review validation records for relevant site equipment.
• Identify training requirements for clinical trial site personnel.
• Ensure clinical trial materials are available before study initiation.

Clinical Investigational Site Management

The selected CRA will manage assigned clinical trial sites throughout study execution.

Responsibilities include:

• Initiating clinical studies at investigational sites.
• Providing protocol and study-specific training.
• Reviewing informed consent forms and narratives.
• Reviewing source documents and clinical records.
• Performing Source Data Verification (SDV).
• Reviewing CRF/EDC data entry.
• Reviewing clinical data queries and coordinating with sites for resolution.
• Completing monitoring visit reports within required timelines.
• Issuing follow-up letters and tracking action items through closure.

Investigational Product Accountability

The role includes oversight of Investigational Product (IP) management at clinical trial sites.

The CRA will:

• Ensure adequate initial supply and re-supply of investigational products.
• Review IP receipt, collection, storage and accountability.
• Monitor temperature records and storage conditions.
• Identify and escalate temperature excursions.
• Review investigational product administration records.
• Coordinate destruction or return of expired and used IP.
• Ensure appropriate IP reconciliation and documentation.
• Review pharmacy/site files and relevant shipment documentation.

Site Contracts and Payments

Responsibilities also include coordination of:

• Confidential Disclosure Agreements (CDA).
• Clinical Trial Agreements.
• Contract amendments where applicable.
• Site invoice generation according to agreements.
• Review and approval of site invoices.
• Payment processing coordination.
• Site payment acknowledgements.
• Reconciliation of payments against completed site and subject activities.

Laboratory and Vendor Coordination

The Clinical Research Associate will liaise with safety laboratories and other clinical trial vendors.

Key activities include:

• Ensuring timely receipt and processing of samples.
• Coordinating release of laboratory reports.
• Identifying and resolving laboratory-related risks.
• Ensuring bioanalytical samples are stored according to the laboratory manual.
• Supporting sample reconciliation and query resolution.
• Helping investigational sites resolve vendor-related issues.

Cross-Functional Clinical Operations Support

The CRA will collaborate with several internal functions, including:

• Data Management – EDC issues, data queries and reconciliation.
• Safety/Pharmacovigilance – SAE-related issues.
• Medical Team – protocol and patient eligibility questions.
• Project Teams – study execution, risks and operational issues.

GCP, Regulatory and Protocol Compliance

A major responsibility of this Clinical Research Associate job is maintaining clinical trial compliance.

The CRA will help ensure compliance with:

• Approved study protocol.
• Study-specific plans.
• Company Standard Operating Procedures (SOPs).
• Applicable regulatory requirements.
• International Council for Harmonisation Good Clinical Practice (ICH-GCP).
• Good Documentation Practices.
• ALCOA-C principles.

The role also involves identifying significant protocol or procedural deviations, escalating issues to the Clinical Operations or Project Lead and supporting appropriate Corrective and Preventive Actions (CAPA).

The CRA may provide training or retraining when required and support clinical trial audits, inspections and quality control visits.

Trial Master File and Inspection Readiness

The Clinical Research Associate will support continuous inspection readiness by ensuring clinical trial documentation remains complete and current.

Responsibilities include:

• Ensuring sites maintain updated Investigator Site Files.
• Retrieving essential documents from clinical trial sites.
• Supporting central/in-house filing.
• Reviewing on-site and in-house study files.
• Performing document reviews according to monitoring and TMF plans.
• Ensuring Trial Master File completeness and inspection readiness.

Educational Qualification

Candidates should possess one of the qualifications specified by Dr. Reddy’s:

• Master’s degree in Pharmacy
• Master’s degree in Life Sciences
• Master’s degree in Biology
• Master’s degree in Biotechnology
• Master’s degree in Biochemistry
• Diploma in Clinical Research

Experience Required

Dr. Reddy’s specifies 2–5 years of research experience for this Clinical Research Associate position.

Candidates with hands-on exposure to clinical trial operations, investigational site management, clinical monitoring, EDC systems, SDV, regulatory documentation or related clinical research activities would be particularly relevant to the role.

Skills Required for Clinical Research Associate

Applicants should have knowledge or experience in:

• Clinical trial operations
• Clinical site management
• Site qualification and initiation
• Clinical trial monitoring
• Source Data Verification (SDV)
• CRF and clinical data review
• EDC systems
• Clinical data query management
• Investigational Product accountability
• ICH-GCP guidelines
• Clinical research regulatory requirements
• Medical terminology
• Pharmacovigilance processes
• SAE coordination
• Trial Master File management
• Investigator Site File management
• CAPA and deviation management
• Audit and inspection readiness
• Microsoft Office

Strong communication, negotiation, project management, analytical and problem-solving abilities are also important for this position.

About Dr. Reddy’s Biologics

Dr. Reddy’s Laboratories operates a Global Biosimilars business supported by integrated capabilities spanning product development, manufacturing, clinical development, regulatory activities and commercialization.

Its biologics organization works across multiple therapeutic areas and supports complex global biosimilar clinical development programs.

For clinical research professionals, the position provides exposure to cross-functional clinical operations involving investigators, clinical sites, Data Management, Safety, Medical teams, laboratories and external vendors.

Benefits

According to the job posting, Dr. Reddy’s provides employee benefits that include:

• Career development opportunities
• Personalized learning programs
• Joining and relocation support
• Maternity and paternity benefits
• Learning and development opportunities
• Medical coverage for employees and eligible family members
• Life coverage

Specific benefits may depend on company policies and employment terms.

How to Apply

Application Link