Bioavailability and Bioequivalence Services Clinical Data Management Central Reference Lab Clinical Trials and Research Site Management Services   SITE MANAGEMENT SERVICES   Services Provided Site Management Organisation Site Management Services Study Coordinators Resourcing Services       SITE MANAGEMENT SERVICES - SITE COORDINATOR RESPONSIBILITIES PRE STUDY . Familiarize with the Sponsor's protocol . Design and maintain organizational tools (excel sheets, logs, forms, equipments, etc)    to conduct the study accurately . EC Submission . Coordination and participation during Site Initiation STUDY . Ensure proper written ICF from each subject is obtained to the participation in the study . Screen and enroll the potential subjects according to the protocol's inclusion and exclusion criteria . Assign study subject numbers . Randomization, if applicable . Ensure safety and welfare of study subjects . CRF/ eCRF entry . To maintain adequate source documentation . Maintain adequate and accurate CRF for each study subject that records all observations and data during    the study according to the CRF completion guidelines specific to the study . Concomitant medications accountability . Report of AEs, SAEs to PI, Sponsor and EC according to protocol requirements or applicable regulations . SAE Worksheet . Communicate with Sponsor regarding study activities as necessary . Coordination and participation during Monitoring Visit . Coordination and participation during Site Close Out . Query resolution . Research Pharmacy (study drug receipt, dispensing, accountability, etc) . Phlebotomy or coordination of lab activities . Biological sample centrifugation/ separation . Biological sample shipment coordination . Disburse patient travel reimbursements . Maintain records of receipt, dispensing, and return of all clinical supplies POST STUDY . Communicate with Sponsor regarding study activities as necessary . Query resolution . Filing, storage and archival of study documents . Prepare for audits and inspections . Meet with sponsor to discuss the conduct and review of study data . Any other requests by the Principal Investigator

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