Opening For The Position Of Sr. CRA
2 - 7 YearsAhmedabad
Job Description
Job Profile :
Identify and qualify potential investigators
To review research protocols and amendments, informed consent documents, case report
identification & collection of necessary documents
Support for Regulatory and EC submissions
Responsible for training of site study team
Assist for the preparation and presentation at investigator meetings
Conduct of monitoring visits
Source document verification, timely collection of documents like CRF, DCFs etc from the site along with SAE reports
Study updates & Coordination with Labs
Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor management for the study.
Ensure Escalation & issue management at site level/ vendor level.
Responsible for site-closeout & follow up activities in order to maintain documents at the site.
Evaluates the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
Assist with the audit of an investigational siteCompany Profile
Identify and qualify potential investigators
To review research protocols and amendments, informed consent documents, case report
identification & collection of necessary documents
Support for Regulatory and EC submissions
Responsible for training of site study team
Assist for the preparation and presentation at investigator meetings
Conduct of monitoring visits
Source document verification, timely collection of documents like CRF, DCFs etc from the site along with SAE reports
Study updates & Coordination with Labs
Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor management for the study.
Ensure Escalation & issue management at site level/ vendor level.
Responsible for site-closeout & follow up activities in order to maintain documents at the site.
Evaluates the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
Assist with the audit of an investigational siteCompany Profile
Cliantha Research, a leading life science company, is a global full service Contract Research Organization with integrated offerings in Clinical, Bioanalytical, Dermatology, Biometrics, Pathology and Formulation services.
Our facilities are inspected and audited by global regulatory bodies like USFDA, ANSM (French regulatory agency), MCC (South African regulatory agency), AGES (Austrian regulatory agency), AEMPS (Spanish regulatory agency), WHO, UK-MHRA, Thai MoPH, MOH Turkey and various international companies.
Our facilities are inspected and audited by global regulatory bodies like USFDA, ANSM (French regulatory agency), MCC (South African regulatory agency), AGES (Austrian regulatory agency), AEMPS (Spanish regulatory agency), WHO, UK-MHRA, Thai MoPH, MOH Turkey and various international companies.
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