Clinical Research Associate

CLINICAL RESEARCH ASSOCIATE

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 perform pre-investigational site visits
  • To participate in site nomination process; evaluate site capability and make recommendation for inclusions for clinical trial
  • To make regular contacts with investigators and complete the necessary forms
  • To facilitate preparation and collection of site level documents
  • To facilitate communication between sites and MMR as appropriate
  • To perform initiation visits
  • To perform monitoring visits according to the monitoring plan (if available), and to check informed consents, SDV as well as noting protocol violations
  • To write site visit reports and complete all the necessary forms and contact reports to assign a date for an upcoming visit at the end of each monitoring visit
  • To provide all kinds of logistic support required for a project (Lab. supplies, etc.)
  • To facilitate and manage site drug supplies
  • To participate in trial site training activities, as assigned
  • To be constantly alert for AE/SAE for immediate reporting
  • To fill in visit log forms and prepare updated status reports
  • To ensure site activities are in line with milestones (i.e. startup, patient recruitment, closeout, etc.)
  • To manage patient recruitment implementing appropriate contingency plans as needed
  • To perform site close out visit
  • To assure compliance of GCP, ICH and MMR/Sponsor SOP (Informed Consent Process, Source Data Verification, AE and SAE Reporting, SUSARs, Protocol, Drug Accountability etc.).
  • To resolve deviations from standards by taking remedial action and training
  • To perform data query resolution process (both at Site and with Data Management)


3. ORGANIZATIONAL POSITION AND REPORTING:
  • Reports to: Project Manager
  • Receive Reports From: N/A


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


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