Dr. Reddy’s Laboratories Hiring Clinical Research Associate Hyderabad

Dr Reddy’s Laboratories, a global leader in pharmaceutical manufacturing, is seeking a qualified Clinical Research Associate for its Hyderabad location. This role requires a master’s degree in pharmacy or life sciences and 2-5 years of research experience. Join a dynamic team committed to advancing healthcare through innovative clinical trials.

Job Description

Job Summary

We seek an experienced Clinical Research Associate to join our team in Hyderabad. This role involves processing, reviewing, and receiving clinical data from therapeutic groups and internal and external investigators and ensuring accurate and timely data delivery to clinical teams.

Roles & Responsibilities

• Facilitate Study startup activities at the Clinical Investigational Site
• Conduct Feasibility & assess the data
• Conduct site qualification visits to assess the suitability of sites for study conduct, including review of Investigator qualifications, site staff adequacy, site facilities, and  patient pool & share feedback with the 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 of clinical investigational sites
• Provide study protocol and related training
• Review Informed Consent forms and narrative
• Review source records, perform SDV
• Review CRF data entry and data queries and coordinate with sites to resolve
• Ensure timely completion and review of site visit reports, address action items via follow-up letters, and track action items until closure.
• IP accountability and reconciliation
• Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites.
• Provide adequate oversight of IP collection, storage, and temperature monitoring, including reviewing the log and administering IP to study subjects.
• Identification of any temperature excursions and suitability of IP for subject administration
• Ensure the destruction of expired on-site or the return of such IP to another local depot, per the study requirements, and provide& adequate documentation for the same.
• Review of logs completion, relevant shipment filing, 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 the clinical trial agreement.
• Review and approval of site invoices and submission to the 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.
• Lliaise without lab for time sample receipt, processing, and release of reports, as well as identifying and resolving lawsuits/risks.
• Ensure that the Bioanalytical samples are stored according to the lab manual’s storage conditions, including reconciliation and query resolution.
• Liaising with other vendors and helping sites with any query resolutions for vendor-related activities
• Liaising with internal project teams, including, but not limited to, Data Management for EDC issues, data queries and reconciliations, the Safety team for SAE-related issues, and the Medical team for any protocol / eligibility-related queries, etc.
• Liaising with Internal & External Stakeholders
• Ensuring Compliance with Protocol & Applicable study plans, SOPs, GCP and regulatory requirements
• Ensure compliance with the Protocol
• Ensure compliance with study plans, applicable SOPs and related regulatory requirements
• Ensure compliance with ICH GCP
• Ensure compliance with 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 the 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 the Investigator site file
• Retrieval of essential documents from sites for house filing / Central files
• Review on-site and in-house files at defined frequency per monitoring / TMF plan for stuStudysure adequacy of TMF for all-time inspection readiness

Qualifications

• Educational Qualification: Master’s degree in pharmacy, life sciences, biology, biotechnology, or biochemistry, or a diploma in clinical research.
• Work Experience: 2-5 years of research experience.
• Technical Skills: Proficiency in clinical trial operations, market research, regulatory guidelines (GCP, ICH), medical terminology, and EDC systems.
• Behavioural Skills: Excellent communication, negotiation, and interpersonal skills, strong management and analytical abilities, and an adult-oriented mindset.

How to Apply

Interested candidates can Apply here. 

Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs