Overview
Obtain Written Informed Consent From Study Subjects
Review Medical Records And Ascertain Eligibility Of Subjects
Carry Out Medical Examination Of Volunteers As Well As Subjects As Required
Responsible For Organization And Conduct Of Clinical Studies In Conformance To Gcp Standards, Sops, And Applicable Regulations
Conduct Trials With Compliance To Sops And Gcp/Glp Requirements
Manage Medical Emergencies (If Any)
Responsible To Ensure Proper Reporting Of Adverse Events
Supervise The Safety Related Activities Of Clinical Staff During The Study Conduct.
Responsible For Overall Planning, Conduct, Documentation And Reporting Of Bioequivalence And Pharmacokinetic Studies In Conformance To Gcp Standards, Sops, And Applicable Regulation
To Ensure That All Professional And Technical Personnel Involved In The Conduct Of The Study Have Job Descriptions And Records Of Training, Qualification And Experience, Which Support Their Ability To Undertake The Tasks Assigned To Them
Review Of Informed Consent Documents (Icf) And Case Record Forms (Crf) For Clinical Studies
Skills / Roles I hire for
medical examinationclinical studiesManage medical emergenciesQualityAuditorCustodianCommunication Skills