Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach.
Post : Experienced / Senior Clinical Research Associate
Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include:
• Pharmacy Technicians
• Pharmaceutical/Device Sales Representatives
• Biotech Engineers
• PhD/Pharm.D candidates
• Health and Wellness Coordinators
• Research Assistants.
As a CRA, you will specifically be responsible for the following:
• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
• Bachelor's degree with at least 2-4 years of eperience as a Clinical Research Associate;
• Willing to travel approximately 60-80% nationally;
• Familiarity with Microsoft® Office; and
• Strong communication and presentation skills a plus.
Qualification: Bachelor's degree
Location: Maharashtra - Navi Mumbai
Industry Type: Pharma
Functional Area: CRA
End Date : 30th April, 2020
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