Clinical Research Associate (CRA)

Auxein Medical; Kundli; On-site; INR 600,000 - 900,000; Full time

Job summary

Auxein Medical in Kundli, Haryana, India is seeking a Clinical Research Associate with 5+ years in medical device studies. The candidate will prepare and submit study documents, assist investigators, and monitor site activities ensuring adherence to protocol and ICH-GCP guidelines.

You will coordinate data collection, manage site logistics, and train staff to minimise deviations while maintaining real-time reporting and compliance across the trial lifecycle.

Qualifications

• Clear communication with cross-functional teams and sites.
• Strong attention to protocol details and regulatory requirements (ICH-GCP).
• Ability to work effectively in a medical device study environment.

Responsibilities

• Prepare study documents per international and local guidelines.
• Submit study documents for ethics committee and regulatory approvals.
• Initiate the study after approvals and assist investigator in patient recruitment.
• Collect data as per protocol and share with reporting manager in real time.
• Ensure patient follow-ups are conducted timely and data is updated promptly.
• Monitor site visits as per plan and document actions and follow up.
• Maintain site logistics, inventory, and implant accountability.
• Identify risks and mitigate protocol deviations.
• Train site staff on protocol and trial procedures.
• Support ITMF filing and archiving of trial documentation.

Skills

Communication

Attention to detail

Team collaboration

Education

Medical/Biomedical degree

Job description

Role & responsibilities

• Preparation of study documents as per international and local guidelines.
• Submission of study documents for necessary approval from ethics committee and applicable regulatory body.
• To initiate the study after the approvals.
• To assist the doctor (study investigator) in recruitment of the patients in the study.
• Collection of data as per study protocol and sharing with reporting manager in real time.
• To ensure that recruited patients turn up for follow up visits timely.
• Sharing of follow-up visits data with reporting manager in real-time.
• To ensure that studies are done in compliance with study protocol, international guidelines (ICH-GCP), and applicable local regulations.
• Train and guide site staff in the protocol and trial procedures to minimise protocol deviations (PDs)
• Performing on-site monitoring visits according to plan, document actions and follow up on action plans.
• Maintain site logistics, inventory and accountability of implants used.
• Identify potential risks and proactively act to prevent or mitigate.
• Collection and management of study documents.
• Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF).
• Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable.
• Attend regular meetings with reporting manager.
• Any other studies related task assigned by reporting manager.

Required Candidate profile

Any Medical/ Biomedical or related field graduate with Min. 5 years of relevant experience, currently working as a CRA with Medical Device industry, Excellent communication and pleasing personality.