Monday 19 September 2011

Opening for Clinical Research Associate at Max Neeman, India.


Position Title: Clinical Research Associate
Location: New Delhi / Mumbai / Pune / Hyderabad / Bengaluru
Qualifications/who should apply: Only MBBS candidates with 1 year of experience as Research Coordinator should apply
Job Description:  To successfully conduct the listed site visits as required by client/study -- Pre Study Site Selection, Site Initiation, Interim Monitoring, Site Close out. Meet with Clinical Investigators and staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff. If required train the study site team. To confirm the appropriateness of the site for the study in all aspects and ensure that all documentation required to initiate the study is complete. Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor/CRO & NMI SOPs. Monitor and track patient enrollment and study progress. Perform site monitoring visits to include review of source document, case report form, ICD, Patient Diary, Investigator Site Binder, other documents as applicable. Ensure the timely accurate and complete collection and submission of study data. Identify, address, and resolve issues and problems as they might occur.
At Study Completion: Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO. Ensure that appropriate study documents are complete and properly filed. Archival with Inventory list of Source documents/ CRFs/ CTM/ Others at site. Prepare the site for possible Regulatory/ FDA inspection.Prepare the site for possible Internal and/or Client Audits. Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities. To ensure 100% adherence to the monitoring and study plan. Coordinate with Site, Vendors, Client, Regulatory & NMI to maintain best practices through out the course of the study. This position requires 50-70% Travel. To maintain confidentiality of clients/ projects & related information, as applicable. To complete tasks assigned by management as deemed necessary.

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