Clinical research associate

•	Conducting research and maintaining proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation;
•	Customize and adapting country/site Informed Consent Forms and reviewing study documents according to local regulations;
•	Communicating with study sites regarding essential document collection and assisting with IRB/EC submissions;
•	Completing review of essential documents following Essential Document Checklist QC;
•	Providing update status to the teams; update appropriate study-tracking tools, and maintaining project tracking systems as required for assigned projects;
•	Identifying site issues during start-up process and participate in the resolution.  
 

•	Performing identification of suitable sites for studies and coordinated global efforts for site identification;
•	Communicating with clinical trial sites to collect data for feasibility, site ID, and to build the investigator database;
•	As a primary contact, building local relationships with key research sites and Key Opinion Leaders while providing to Global Feasibility team with country specific data for site proposals;
•	Contribute to the country plan for the study by identifying required number of sites, type of sites, recruitment rates, and identifying key study challenges validating feasibility / site ID assessment 

•	Coordinating, organizing and maintaining all study documentations including source documentation, case report forms, study and regulatory binders and patient binders;
•	Recruiting several subjects for various studies, scheduling study visits and performing necessary tests including blood, urine and serum;
•	Provide patient/family/medical/nursing staff education related to clinical trials in order to effectively complete study specific procedures and documentation;
•	Preparing and processing documentations through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments and adverse events reporting;
•	Preparing and participating to audits conducted by sponsors and other oversight entities such as national and international regulatory Agencies.

•	Collection of patient’s information, recording all data and completing case report form;
•	Analyzing, collecting and preparing data in order to evaluate and maintain database accuracy;
•	Reviewing medical records and assuring accuracy and completeness;
•	Organizing, counting, and providing clinical trials medication to patients while maintaining pharmacy organization;
•	Collecting, preparing and shipping biological samples according to standard protocols.