Life Sciences CRA Job Openings at Advanced MedTech Solutions (AMS)
Job Role: Clinical Research Associate
Company: Advanced MedTech Solutions (AMS)
Location: Vadodara
CTC: Up to ₹6 LPA
Experience: 3 – 5 Years
Interview Mode: Virtual
Work Mode: Onsite (6 days working)
Industry: Medical Devices & Equipment
About the Role
Advanced MedTech Solutions (AMS) is seeking a Clinical Research Associate (CRA) with hands-on experience in clinical research, site management, and regulatory documentation. The role involves end-to-end clinical trial support – from investigator recruitment and site initiation to monitoring, audits, and final data review – while ensuring compliance with GCP guidelines and sponsor SOPs.
Key Responsibilities
- Participate in investigator recruitment and conduct qualification visits for potential sites.
- Collaborate with the Study Start-up Group to ensure timely regulatory submissions and study initiation.
- Conduct site initiation visits, train site staff on study protocols, regulatory requirements, e-CRF completion, and EDC systems.
- Perform on-site monitoring visits, ensuring adherence to Good Clinical Practices (GCP), protocol compliance, and data integrity.
- Conduct periodic site file audits and reconcile Investigator Site File (ISF) with Trial Master File (TMF).
- Validate source documentation, review CRFs, resolve data queries, and prepare monitoring reports.
- Manage clinical trial materials, including investigational product accountability and return logistics.
- Coordinate with central/core labs (ECG, Echocardiography, QCA, OCT/IVUS).
- Support regulatory submissions (online & offline) across different countries.
- Coordinate with DSMB, Steering Committees, and CEC; prepare minutes of meetings.
- Assist in preparing study presentations for regulatory bodies, national & international conferences.
Desired Skills & Competencies
- Strong knowledge of clinical trial processes, GCP, and regulatory guidelines.
- Hands-on experience in site management, monitoring, and audits.
- Proficiency in eCRF/EDC systems and clinical data management.
- Excellent communication, training, and stakeholder coordination skills.
- Ability to prepare regulatory documentation and study presentations.
Education Qualification
UG: B.Sc in any specialization
PG: M.Sc / M.S. (Life Sciences or related specialization)
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