Ajay Kumar Email & Phone Number

• Strong knowledge of clinical trials and clinical management• Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements. • Preparation and review of SOP’s, protocols, IBs, CRFs and other study related documents• Preparing & review of study report.• Excellent Analytical, Communication, and Team Working skills.• Organizing and Supervision of overall clinical activities.

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  Clinical Research Associate Trainee

  Gratisol Labs Llc

  Dec 2012 - Present - Hyderabad Area, India

  • Maintaining the Trial Master Files (TMF) for the studies in progress.• Facilitate the Import, Delivery and Return of Clinical Trial Medication and other Clinical Trial Materials to Investigator Sites. Monitor the storage and usage of Clinical Trial Materials by Investigator Sites. • Maintain regular and effective verbal and written communication with clinical project management team members and, where appropriate, the Sponsor. • Develop a comprehensive knowledge of the clinical study protocol and other relevant documentation. Completed and managed all clinical trial specific documents, including detailed source documentation [case report form (CRF) or electronic case report form (eCRF)].• Experience with Electronic Data Capture.• Experience maintaining Trial Master Files and Patient files• Obtain key GCP documents prior to Site Initiation for appropriate filing and distribution. • Maintain regular contact with Investigator & Site staff by means of letters, emails and weekly telephone calls. Provide site with necessary study updates and documents. • Develop and maintain a working knowledge of current SOPs and ICH-GCP & FDA requirements.