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
ABAC
