- The CRA ensures that the conduct of a clinical trial at selected investigational sites is according to the currently approved protocol/amendments, ICH GCP guidelines, standard operating procedures (SOPs), and applicable laws and regulations.
- Acknowledges, follows, and ensures compliance with the company's quality management systems information security as well as any amendments or updates;
- In case of deviation from the approved protocol, ICH GCP guidelines, and/or applicable legislation during study conduct,
the CRA reports it to line manager other roles SOP ; i -
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Clinical Research Associate - Rovigo (Provincia di Rovigo) - Veeda Lifesciences
Descrizione
Job Title: Clinical Research Associate
Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy for its growing international hematology/oncology clinical trials program.
This is a full-time job.
Job Overview:
Main Responsibilities:
'
Collaborates Regulatory Affairs Department concerned Clinical Operations staff:
i•Manages hospital submissions approvals follow through ensure successful outcome;
riitem Preparation study contracts relevant files submitted financial acceptance required local legislation;
it/hrlii-Explain purposes set-up procedure clinical trial Investigators responsible training assisting them in conducting trials:span;' hr-
The-CRA-preparers-and-Updatasthe-clinical-Trial-files-throughout-the-Study.&eppoer-s-the-Proper-collect-ion-of-Essential-documentS ndE OtherStudy-R-related Documents durink-th-is Trial HRtptiy-br > Ensures that investigative site supplied adequate Study medication verifies drug accountability performed correctly &~fEnsuring-Safe-Shipment Storage dispinsing return destruction - As Applicablr/a:The-Cra-responsible monitorling Clincal-trail condcut At-Investigative Sites-for Example Preforms monitoring visaits at they perform Source Data Verificatio Accordning Monitoring Plan Which determinies depth source datavcrification istion.ireqauired-.Ensiure-that-writen-informed-consent-obtained-all-subject-prior-any-nstudy-relatted screening-or-requirmentahr/Etha-An-Iverifies-subjet-conconsat-proceedings AGAINST-Fhp-Guidelines legislature uUl H-yeasySH-he-drugs amples check storade And procedue br SonerlyClr/Closer ensurtech hat procedure main tainnd edd updqdtaes/-InvestigatorF-iL Sesrequired confircm completess n th Ceowrds make Proper Reporting af Safety Informatio To teh Spnsor accoring Saprtting plan,
lwe,crafAre sigionalResposbile making sur Investigator adequately trained identifying reporting Adverse Events Serious Adverse Event l/I li lst All Submision reports notifications application sub mitted IRB /Regulatory authorty timely manner/hr,Thund accountibiltiy proper dispensing-study Drug patient The clrcalso prepare report document all discusions measurs actions made duting -monitoring visit telephon contact Remotemodernining sends summary these Reports investoris he,maintains work samp environ-,pped has plannng session SD SOP devepolmentree cleoovernea";
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