Are you passionate about advancing healthcare through clinical research? Biotech Healthcare is currently seeking a dedicated Clinical Research Associate (CRA) to join our team in Ahmedabad, Gujarat. This exciting role offers the opportunity to contribute to vital clinical trials while ensuring compliance with regulatory guidelines and supporting trial sites.
About Biotech Healthcare
Biotech Healthcare is a leading organization in the biopharmaceutical industry, committed to improving patient outcomes through innovative research and development. We promote an inclusive work environment and are dedicated to diversity, ensuring no discrimination based on gender, race, religion, age, sexual orientation, disability, or any other ground.
Job Description
As a Clinical Research Associate, you will play a key role in the successful execution of clinical trials by managing documentation, coordinating with trial sites, and ensuring compliance with regulatory requirements. Your responsibilities will include:
- Regulatory & Ethics Committee Coordination:
- Prepare, submit, and coordinate Ethics Committee and regulatory dossiers for clinical trials at multiple sites.
- Ensure timely registration of clinical trials on regulatory platforms as per local regulations.
- Clinical Trial Site Management:
- Setup trial sites ensuring all necessary materials, including investigational medicinal products (IMPs), are available.
- Conduct timely site visits including site initiation, routine monitoring, and close-out.
- Investigational Product & Supply Management:
- Order, track, and manage investigational products and trial materials, ensuring compliance with SOPs, local regulations, and ICH-GCP guidelines.
- Coordination and Reporting:
- Liaise with clinical trial sites and investigators, ensuring timely data collection and resolution of site-related issues.
- Additional Responsibilities:
- Support in the preparation of investigator agreements and identification of new investigators while assisting with various clinical operations tasks.
Desired Candidate Profile
To be successful in this role, you should meet the following criteria:
- Education: A Bachelor’s degree in Optometry, Pharmacy, Clinical Research, or Pharmacology.
- Experience: 0-1 year in clinical trial processes, including data collection, management, and regulatory compliance.
- Skills:
- Strong analytical and problem-solving capabilities.
- Effective communication and collaboration skills.
- A proactive approach to improving clinical processes.
- Ability to work as a team player with excellent coordination abilities.
