Site Coordinator

SITE COORDINATOR

1. JOB SUMMARY AND OBJECTIVES:
  • To accomplish the tasks of a project assigned by the Project Manager
  • To initiate, monitor and close-out clinical study sites
  • To provide the Project Manager effective, correct and timely information on the projects
  • To be the central point of communication between MMR and Investigators for all clinical trial related activities
  • To assure trials are conducted on time while being fully GCP, ICH and MMR/Sponsor SOP compliant


2. MAIN DUTIES:
  • To be present at the site throughout the trial and maintain all trial related documents
  • To organize all necessary documentation of tasks and makes sure that tasks are completed in relation to protocol assigned by Principle Investigator (PI)
  • To make sure that the trial patient receives the medication as prescribed by PI
  • To collect all trial data required by PI
  • To make data entries into the CRFs under the supervision of investigators
  • To facilitate patient visits at sites and coordinate patient visit appointments
  • To report any Protocol violations and deviations to sponsor and inform the PI
  • To organize all kinds of logistic support required for a project (drug supplies, etc.)
  • To be constantly alert for AE/SAE for immediate reporting
  • To inform the PMs and CRAs in case of any problem associated with AE/SAE reporting
  • To organize sample collection and shipment
  • To visit MOH and Ethical Committee to follow up the status of the submissions
  • To organize the payment of patient travel expenses upon sponsor’s approval.
  • To fill in patient visit log forms and prepare updated status reports
  • To facilitate preparation and collection of site level documents
  • To facilitate communication between sites and MMR or Sponsor as appropriate
  • To participate in trial site training activities, as assigned
  • To ensure site activities in line with milestones (i.e. start-up, patient recruitment and close out, etc.)
  • To assure compliance of GCP, ICH and MMR/Sponsor SOP (Informed consent process, Source Data Verification, AE and SAE reporting, IN, Protocol, drug accountability etc.).
  • To resolve deviations from standard by taking remedial action
  • To provide support for query resolution process at site by checking the study related documentation
  • To provide study related information to the Project Manager and/or to the study CRA/Sponsor when required


3. ORGANIZATIONAL POSITION AND REPORTING
  • Reports to:
    • Expense reports to MMR Human Resources Executive
    • Receive reports from: NA


4. IDEAL BACKGROUND
  • Education:
    • Education in a health care or scientific discipline.
  • Languages:
    • Preferable English (oral and written)
  • Experience/Professional requirement:
    • Demonstrates ability to coordinate, organize and communicate
    • Knowledge and experience in clinical development process including local regulations, ICH-GCP and other related ability to work on teams and deliver on commiments
    • Computer literacy



Please send your applications with a photograph to Aslin OSANÇLIOL at aslino@monitorcro.com.