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Research Associate

Job Description - Research Associate


Job Description









  • Travel to site and monitor the clinical trial data generated at sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed.

  • Take lead on study activities and perform co-monitoring visits with CRAs to support and guide them as per the requirements.

  • Preparing site visit reports within timelines

  • Ensure that site staff is qualified, experienced, and adequately trained to perform their role and responsibilities. 

  • Ensure study data collected is accurate and verifiable.

  • Manage clinical trial site payments and handle any ongoing negotiations.

  • Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study.

  • Act as a mentor to site staff and provide continuous support and guidance as required.

  • Ensure study documents are appropriately maintain in their respective files till archival

  • Adheres to protocol, regulatory requirements, good clinical practice, and standard operating procedures.

  • Assesses the trial site and applicable personnel on an ongoing basis.

  • Ensures compliance with the patient-consent process and other study procedures.

  • Verifies the receipt, handling, accounting, storage conditions, and availability of clinical trial material. Verifies compliance and quality of collected study data. 

  • Ensures compliance with the procedures to apply in the event of serious adverse events.

  • Prepare an appropriate intervention plan to avoid redundant errors and deviations.

  • Verifies investigator site files and ensure it is consistent with in-house files.

  • Any other assigned task/activities as per the need of study and organization to be completed.


 



 

Work Experience

 4-5 years of Monitoirng experience in Sponsor/ CRO setting 

Education

Graduation
Post Graduation in Pharmacy

Competencies

1. Strategic Agility
3. Customer Centricity
5. Result Orientation

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