Dr.Reddys Laboratories Ltd Hiring for Clinical Research Associate

Dr.Reddys Laboratories Ltd Walk-in Interview 2025.Dr.Reddys Laboratories Ltd Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue… 

Important Details :

• Selection Process: The selection will be on the basis of Interview.
• Mode of Interview: Face to face
• Interview Rounds of Interview: HR

Vacancy details:

• Department: Clinical Research Associate
• Educational qualification: Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research
• Minimum work experience: 2 – 5 years of research experience
• Job Location: Hyderabad

Job Description : Greeting from Dr.Reddys Laboratories Ltd..!!!!

We are seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups.

Roles & Responsibilities

Facilitate Study Start up activities at Clinical Investigational Site

Conduct Feasibility & assess the data

Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project team

Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions

Identify the training needs for the site to perform adequate conduct of trial

Ensure supply of clinical trial material to sites before study initiation

End to End clinical investigational site management:

Initiate the study at clinical investigational sites

Provide study protocol and related trainings

Perform review of Informed Consent forms and narrative

Perform review of source records, perform SDV

Review of CRF data entry, data queries and coordinate with sites to resolve

Ensure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closure

IP accountability and reconciliation

Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites

Provide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjects

Identification of any temperature excursions and suitability of IP for subject administration

Ensure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same.

Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file.

Site Contracts and Site Payment Coordination

Coordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicable

Ensure that site invoices are being generated as per clinical trial agreement

Review and approval of site invoices and submission to payment processing team

Coordinate for the payment release & confirm for site acknowledgements

Perform ongoing reconciliation of payments against site activities including subject visits conduct etc.

Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same.

Ensure that the Bio-analytical samples are stored as per storage conditions mentioned in the lab manual including reconciliation and query resolution

Liaising with other vendors and help sites in any query resolutions for vendor related activities

Liaising with internal project teams including but limited to Data Management for EDC issues, data queries and reconciliations, Safety team for SAE related issues, Medical team for any protocol / eligibility related queries etc.

Liaising with Internal & External Stakeholders

Ensuring Compliance to Protocol & Applicable study plans, SOPs, GCP and regulatory requirements

Ensure compliance to Protocol

Ensure compliance to study plans, applicable SOPs and related regulatory requirements

Ensure compliance to ICH GCP

Ensure compliance to good documentation practices including ALCOA-C

Identification of significant deviations to protocol / plans / procedures, escalation to project lead / clinical ops lead and propose adequate mitigation plans / CAPA, Review of implementation of CAPA / mitigation plans, identify need for training and provide training / re-training in case of any changes

Support audits, inspections / QC visits, as required per study plans

Trial Master File Review and Maintenance for Inspection Readiness

Ensure that sites are timely updating the documents in Investigator site file

Retrieval of essential documents from sites for In house filing / Central files

Review of onsite and in house files at defined frequency per monitoring / TMF plan for study

Ensure adequacy of TMF for all time inspection readiness

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