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1

clinical research manager

  • Organize investigator’s start-up meeting and study site initiation meetings.
  • Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.
  • Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
  • Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
  • Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
  • Participate in global conference calls and meetings to review progress of ongoing clinical trials.
  • Manage the Contract Research Organizations – initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success. Participate in departmental planning sessions, and SOP development.
2

clinical research manager

  • Provide management to the clinical research assistants to ensure that their role and contribution is optimized.
  • Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion Worked on Phase-II neurology study (epilepsy study) Submitting regulatory documents to IRB and Sponsor
  • Developing a preliminary budget and verify all costs
  • Screening and scheduling subjects
  • Performing study/protocol procedures in a detailed, accurate manner
  • Maintaining study files
  • Maintaining the database