Clinical Research Associate

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 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

MAIN DUTIES

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

ORGANIZATIONAL POSITION AND REPORTING

Reports to: Project Manager

Receive Reports From: N/A

IDEAL BACKGROUND

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

Apply !