Research Associate (Quality Assurance)

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About the Organization

BRIC-Translational Health Science and Technology Institute (THSTI) is an Institute of the Biotechnology Research and Innovation Council, Department of Biotechnology, Ministry of Science & Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into products to improve human health.

Job Description

The Research Associate is responsible for the oversight of clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This position involves conducting regular monitoring visits, supporting site operations, and maintaining data quality and compliance across all phases of the clinical trial lifecycle.

• Conduct site monitoring visits from initiation through closeout, ensuring trials are conducted in compliance with the study protocol, GCP guidelines, SOPs, and applicable regulatory requirements.
• Set up trial sites, ensuring that investigational products and essential trial supplies are delivered, stored, and documented appropriately.
• Perform quality checks and execute quality assurance process across clinical operations and clinical laboratories in accordance with GCP/GCLP standards.
• Provide training on protocols and trial procedures to site staff and maintain ongoing communication to support study execution and address issues.
• Support clinical staff through guidance and training as and when needed.
• Create, maintain, and submit all required documentation related to site management, monitoring visits, findings, and follow-up actions.
• Track and manage study progress, including regulatory and ethics submissions, patient recruitment and enrolment, CRF completion, and data query resolution.
• Verify data accuracy through source data/document verification to ensure consistency between CRFs and clinical records.
• Prepare detailed monitoring visit reports and contribute to the preparation and archiving of essential trial documents.
• Assess trial site compliance and escalate quality or protocol deviations to the Project Manager or Senior Leadership as appropriate.
• Collaborate with Clinical Portfolio Management and other internal departments on cross-functional initiatives and project requirements.

Education Qualification/Required Skills & Experience

• Bachelor's in Life Sciences with a minimum of three years of relevant clinical trial monitoring experience.

                                  OR

• Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline with a minimum of 2 years of relevant clinical trial monitoring experience.
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred (Experience as above).

                                 Skills

• Proficient in computer applications, with demonstrated expertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Strong knowledge of ICH-GCP, GCLP, and regulatory guidelines.
• Excellent documentation, communication, and organizational skills.
• Ability to travel frequently to assigned trial sites.
• Detail-oriented with effective time management skills and ability to manage multiple tasks and priorities efficiently.

Salary

Rs. 58,280/-

For more information please check the Link

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