Dr Reddy’s Clinical Research Associate Vacancy For Pharma – Apply Online
Dr Reddy’s Clinical Research Associate Vacancy For Pharma – Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Clinical Research Associate
Hyderabad, Telangana, India
Job Summary
We are seeking a dynamic, independent, and experienced Research Associate in Clinical Management for processing, reviewing, and receiving clinical data and records 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
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, and share feedback with the project team.
- Collect 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 the trial.
- Ensure the 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 training.
- Perform review of Informed Consent forms and narrative.
- Perform review of source records, perform SDV.
- Review 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 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, and temperature monitoring, including review of logs and administration to study subjects.
- Identify 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 the local depot per study requirements with adequate documentation.
- Review completion of logs, filing of relevant shipment documentation in site/pharmacy files.
Site Contracts and Site Payment Coordination:
- Coordinate for CDA, Clinical trial agreements review and finalization, and amendments as applicable.
- Ensure that site invoices are generated as per clinical trial agreements.
- Review and approve site invoices and submit them to the payment processing team.
- Coordinate for payment release & confirm site acknowledgments.
- Perform ongoing reconciliation of payments against site activities, including subject visits conduct, etc.
Liaising with safety lab for:
- Timely receipt, processing, and release of reports.
- Identification and resolution of any issues/risks around the same.
- Ensure Bio-analytical samples are stored as per storage conditions mentioned in the lab manual, including reconciliation and query resolution.
Liaising with other vendors and assisting sites with:
- 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.
- 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 with:
- Protocol.
- Study plans, applicable SOPs, and related regulatory requirements.
- ICH GCP.
- Good documentation practices, including ALCOA-C.
Responsibilities include:
- Identification of significant deviations to protocol/plans/procedures.
- Escalation to project lead/clinical ops lead and proposing adequate mitigation plans/CAPA.
- Reviewing implementation of CAPA/mitigation plans, identifying the need for training, and providing training/re-training in case of any changes.
- Supporting audits, inspections/QC visits as required per study plans.
Trial Master File Review and Maintenance for Inspection Readiness:
- Ensuring that sites are updating documents in the Investigator site file in a timely manner.
- Retrieval of essential documents from sites for in-house filing/central files.
- Reviewing onsite and in-house files at defined frequencies per monitoring/TMF plan for study.
- Ensuring adequacy of TMF for all-time inspection readiness.
Qualifications
- Educational Qualification: Master’s degree in pharmacy/life science/Biology/ Biotechnology/ Biochemistry/Diploma in Clinical Research.
- Minimum Work Experience: 2–5 years of research experience.
Skills & Attributes:
Technical Skills
- Experience in Clinical Trial operations.
- Proficiency in conducting Market research and analysis.
- Knowledge of regulatory requirements and guidelines such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Ability to evaluate medical research data and proficient knowledge of medical terminology.
- Proficiency in using EDC systems for data collection and management in clinical trials.
- Understanding of pharmacovigilance processes.
- Strong MS Office skills.
Behavioral Skills
- Excellent communication, negotiation, and interpersonal skills.
- Excellent project management skills.
- Strong analytical and problem-solving abilities with a keen eye for detail.
- Result-oriented and passionate about delivering value.
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