Company Description InVitro Research Solutions Private Limited (iVRS) is a Contract Research Organization that provides full-service in vitro solutions for pharmaceutical and nutraceutical product development to global pharmaceutical, medical device, and biotechnology companies. The organization focuses on in vitro characterization and bioequivalence studies under rigorous R&D;, regulatory, quality, and compliance standards. iVRS is supported by an experienced team with strong expertise in both clinical and non-clinical regulatory requirements and emphasizes systematic, ongoing training for operational excellence. The team has hands-on experience in planning, executing, and submitting analytical and IVBE studies, including extractable and leachable testing, IVRT, IVPT, and specialized techniques such as feeding tube studies. iVRS follows good laboratory, clinical, and documentation practices, relevant regulatory guidance, ICH guidelines, and robust method development and validation to support efficient regulatory review and high-quality data.

Role Description This is a full-time, on-site Clinical Research Associate (CRA) role based in Sahakar Nagar.

The Clinical Research

Associate will support the planning, setup, and execution of clinical and non-clinical in vitro studies, ensuring adherence to study protocols, regulatory requirements, and organizational SOPs.

Responsibilities include coordinating clinical trial activities, assisting with site preparation and documentation, monitoring study conduct,



and verifying that data collection is accurate, complete, and compliant. The role involves close collaboration with clinical operations, laboratory teams, and regulatory staff, including maintaining study files, participating in audits or inspections, and contributing to continuous process improvement. The CRA will also assist in preparing reports, summaries, and documentation for submissions to regulatory authorities and for internal review.

Qualifications

- Ability to work with clinical research protocols and support end-to-end clinical trial activities, including protocol adherence and documentation.
- Experience as a Clinical Research Associate or in a similar clinical research role, with exposure to Clinical Trials and Clinical Operations.
- Strong research skills, including data collection, analysis, and interpretation in a regulated clinical or laboratory environment.
- Knowledge of Good Clinical Practice (GCP), Valuable Laboratory Practice (GLP), and relevant regulatory guidelines and standards.
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Strong organizational skills, attention to detail, and ability to manage multiple studies or tasks simultaneously.
- Effective written and verbal communication skills, with the ability to work collaboratively in cross-functional teams.
- Prior experience in in vitro studies, bioequivalence, or analytical method validation is an advantage.

📌 Clinical Research Associate (Pune)
🏢 InVitro Research Solutions Private
📍 Pune