Research Associate - Clinical Research

RESPONSIBILITIES

• To be responsible for the review of LCMS-MS Bioanalytical method development, validation and BE study sample analysis report.
• To prepare and review relevant SOPs as per current and applicable regulatory guidance.
• To be responsible for evaluation and checking of ELISA/ LCMS-MS bioanalytical, pre-clinical study analysis of small/large molecules as per GLP guidelines.
• To prepare an audit plan and to conduct onsite and retrospective audits for Bio studies to ensure compliance with SOPs, study protocol, GCP/GLP and regulatory requirements.
• To be responsible for identifying the root cause for non-compliance/deviations observed from study data and advice on resolving queries from a regulatory perspective.
• To handle BE bioanalytical regulatory queries & deficiencies.

DESIRED SKILLS

• Candidate should know of ICH GCP guidelines for conduction of bioequivalence studies and clinical trials.
• Should have experience in designing bioequivalence studies for various therapeutic drug categories.
• Should have experience in BE protocol preparation for different study designs as per regulatory requirements.
• Should have experience in the evaluation of PK data obtained from pilot & pivotal BA/BE studies.
• Should have experience in auditing and monitoring of CRO (clinical & Bioanalytical)
• Should have experience in reviewing BE CRF, clinical & Bio-analytical reports for ANDA /EU / ANVISA/ ROW submission.
• Should know how to prepare BTIF for regulatory submission.
• Should have experience in handling BE clinical, eCTD regulatory queries & deficiencies.
• Should have experience in handling toxicity studies for bulk drug & impurities. PDE Calculations toxicity assessment.
• Should have an understanding of DCGI requirement for obtaining BE NOC, import License about BA/BE