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Senior CRA

1.00 to 5.00 Years   Hyderabad   18 Sep, 2020
Syngene International Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  1. Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
  2. Handling and execution of studies as per protocol, SOP and applicable regulatory requirements in a timely manner as per the agreed timelines in coordination with the study coordinator and Investigator.
  3. Planning and coordinating for the Protocol Training, Study Check-in activities with the study coordinator.
  4. Request, receive the Study Specific pre numbered forms & SOP forms in required number and maintain the timely accountability.
  5. Preparation of Master templates, Coordinating for the Check in activities on check-in day and ensuring the completion of Check-in. Ensure sufficient clinical supplies were in place for the study.
  6. Preparation and compilation of TMF, Raw data, study schedule, Stations as required for the study.
  7. Study Forms uploading and forms generation from Nuleap. Timely checkout of the studies in Nuleap after completion of the study in a timely manner.
  8. Performs and ensures clinic staff activities during the study was ongoing in compliance with protocol and SOPs. Review the generated data periodically while the study was ongoing for completeness and accuracy in compliance to protocol and SOPs.
  9. Distribution of meals to the study subjects as per the protocol requirements.
  10. Performs dosing related activities (such as dosing, dosing supervision, Test Article verification and mouth check).
  11. Collection and online review of the collected data during the study such as Subject ICD, Screening Consent Forms and Sample Processing Logs etc.
  12. Preparation of study updates & protocol status reports in a timely manner and providing for Investigator and study coordinator for review.
  13. Assists and coordinates for the study sample transfer in coordination with study coordinator.
  14. Compilation of Subject Case Report Forms,
  15. Coordinates for the subject safety and follow up.
  16. Preparation and compilation of the Clinical Report along with the summary tables of applicable regulatory and providing for Investigator and study coordinator review.
  17. Involves and assists the study coordinator in review of the study data such as Raw data, TMF and CRFs and Clinical Report etc.
  18. Clinical Report Section & Case Report Form pdf conversion and book marking for the allocated studies as per the timelines.
  19. Initiation, completion of the archival of the study data.
  20. Executes other duties as per the study specific protocol requirements and as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
  21. Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
  22. Works as a member of a team to achieve all outcomes in a timely manner.
  23. Ensure readiness of the department to face regulatory audit by following good documentation practices, GCP & relevant SOPs.
  24. Performs all work in accordance with all established regulatory and compliance and safety requirements.
  25. Perform all work in support of our corporate values: Collaboration, Courage Perseverance & Passion.
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Keyskills :
case report formsbaggage handling systemsstandard operating proceduresclinical suppliesclinical operationsregulatory guidelinesdocumentation practices

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