Dr Reddy’s Clinical Research Associate Job Opening – Apply Online
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 the suitability of sites for study conduct, including review of Investigator qualifications, site staff adequacy, site facilities, 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 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 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 the local depot, per study requirement & adequate documentation for the same.
- Review 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 the clinical trial agreement.
- Review and approval of site invoices and submission 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 and Other Vendors:
- Liaise with the safety lab for timely sample receipt, processing, and release of reports & identify/resolve any issues/risks.
- Ensure that bio-analytical samples are stored as per storage conditions mentioned in the lab manual, including reconciliation and query resolution.
- Liaise with other vendors and help sites with query resolutions for vendor-related activities.
Liaising with Internal Project Teams:
- Liaise 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.
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.
- Identify significant deviations to protocol/plans/procedures, escalate to project lead/clinical ops lead, and propose adequate mitigation plans/CAPA. Review 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.
- Retrieve essential documents from sites for in-house filing/central files.
- Review onsite and in-house files at defined frequency per monitoring/TMF plan for study.
- Ensure 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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