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 are looking for an experienced Clinical Research Associate to join our team in Hyderabad. This role involves processing, reviewing, and receiving clinical data from therapeutic groups, internal and external investigators, and ensuring accurate and timely data delivery to clinical teams.
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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Dr. Reddy's Laboratories Hiring Clinical Research Associate Hyderabad[/caption]
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.
- Behavioral Skills: Excellent communication, negotiation, and interpersonal skills, strong project management and analytical abilities, and a results-oriented mindset.
How to Apply
Interested candidates can apply via
LinkedIn.
https://pharmastuff.org.in/job/dr-reddys-laboratories-hiring-clinical-research-associate-hyderabad
