• To accomplish the tasks of a project assigned by the Project Manager

  • To initiate, monitor and close-out clinical study sites

  • To provide effective, correct and timely information on the projects to the Project Manager

  • To be the central point of communication between MMR and Investigators for all clinical trial related activities

  • To make sure that trials are conducted on time while being fully GCP, ICH and MMR/Sponsor SOP compliant


  • To perform pre-investigational site visits

  • To participate in site nomination process; evaluate site capability and make recommendations for site inclusions for clinical trial

  • To make regular contacts with investigators and complete the necessary forms

  • To facilitate preparation and collection of site documents

  • To facilitate communication between sites and MMR as appropriate

  • To perform site initiation monitoring, and site close out 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 and to implement appropriate contingency plans as needed

  • To make sure that compliance for GCP, ICH and MMR/Sponsor SOP (Informed Consent Process, Source Data Verification, AE and SAE Reporting, SUSARs, Protocol, Drug Accountability etc.). is in place

  • To resolve deviations from standards by taking remedial action and training

  • To perform data query resolution process (both at the Site and with Data Management)

  • To assist CRA-II and CRA-III for the conduct of all activities related to initiation, conduct and completion of projects


  • Reports to: Project Manager

  • Receive Reports From: N/A


  • Education: University level education in health care or scientific discipline.

  • Languages: Fluent English (oral and written)

  • Experience/Professional requirements:

      ✓ Demonstrates coordination, organization and communication skills

      ✓ Knowledge and experience in clinical development process including local regulations, GCP and ICH fundemantals

      ✓ Ability to work in teams and deliver commitments

      ✓ Computer literacy