A Clinical Research Associate (CRA) is a professional who plays a critical role in the field of clinical research. Their primary responsibility is to ensure that clinical trials are conducted in accordance with applicable regulations, guidelines, and protocols.

Key Responsibilities:

• Protocol Compliance: Ensure that clinical trials are conducted according to the approved study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Site Selection and Initiation: Identify and evaluate potential investigational sites for participation in clinical trials. Conduct site initiation visits, train site staff on protocol requirements, and ensure all necessary documentation is in place.
• Monitoring: Perform routine monitoring visits to assigned sites to verify the integrity of clinical data and ensure compliance with study procedures. Collect, review, and verify source documentation and case report forms (CRFs) for accuracy and completeness.
• Data Management: Collaborate with data management personnel to ensure accurate and timely data collection, reporting, and resolution of data queries. Review data listings and tables to identify discrepancies or inconsistencies.
• Safety Reporting: Monitor and report adverse events (AEs) and serious adverse events (SAEs) to the sponsor, ethics committees, and regulatory authorities as required by regulations and protocols.
• Regulatory Compliance: Ensure that all required regulatory and ethics committee submissions are completed accurately and in a timely manner. Assist in the preparation and review of regulatory documents, such as clinical trial applications and informed consent forms.
• Documentation and Record Keeping: Maintain trial-related documentation, including study files, essential documents, and correspondence. Ensure that all trial-related materials are complete, organized, and stored securely.
• Relationship Management: Establish and maintain effective relationships with investigators, study coordinators, and site personnel to facilitate study conduct and address any issues or concerns that arise during the trial.
• Study Closeout: Conduct site closeout visits and ensure that all required study documentation and supplies are returned to the sponsor or properly archived. Assist in the preparation of study reports and final study data for submission to regulatory authorities.
• Continuous Learning: Stay updated on relevant regulations, guidelines, and industry best practices. Attend training sessions and professional conferences to enhance knowledge and skills in clinical research.

Qualifications and Skills:

• Bachelor's degree in a scientific or healthcare-related field (or equivalent experience) such as MSc. Clinical Research M. Pharm, Pharm D medical and Paramedical degree.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g., FDA, ICH).
• Prior experience working as a Clinical Research Associate or in a related role is preferred.
• Excellent organizational, communication, and interpersonal skills.
• Attention to detail and ability to work independently and as part of a team.
• Proficiency in using clinical trial management systems and electronic data capture systems.
• Willingness to travel to clinical trial sites as needed (domestic and international)

Patanjali Research Foundation is an equal opportunity employer and does not discriminate against any applicant because of race, colour, religion, gender, national origin, age and physical disability.

How to Apply

• Write to jobs@patanjali.res.in with your detailed CV and career aspirations.
• Mention Clinical Research Associate, citing respective Job Code.
• List three professional references other than your friends and family.