Role & responsibilities To search a qualified doctor and hospital site(s) for post-marketing clinical study on orthopedic implants (trauma and arthroscopy studies).
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 in office 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.

📌 Clinical Research Associate Cra Sonipat
🏢 Auxein Medical
📍 Sonipat