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Hiring CRAs for Bangalore Location

Job Description Details for CRA:
  • Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
  • Participates in the identification of potential investigators and clinical sites, conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
  • Assists / Coordinates with Site, Vendors, Client, Regulatory & CRO to maintain best practices throughout the course of the study
  • Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
  • Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings (if applicable) and prepares reports.
  • For patient PK studies: Oversees subjects visits activities; such as check-in activities, study IP administration, samples collection, process, storage and transport as per the protocol and study specific manuals.
  • Monitor and track subject enrollment and study progress; Ensure the timely, accurate, complete collection and submission of study data
  • Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
  • Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
  • Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
  • Assists in the close out of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site close out visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study close out reports.
  • Assist the Sponsor/CRO in problem Identification, address issues and problems (as they might occur) and resolve by providing consultation on monitoring and study related activities to ensure 100% adherence to the Protocol, study plans, GCP, applicable regulatory requirements and company SOPs.
  • Prepare the site for possible Internal and/or Client Audits & Performs miscellaneous job-related duties as assigned.
  • Ready to travel and perform activities