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.