1. Identify and qualify potential investigators to ensure that the sites have adequate time and can fulfill their obligation to the study.
2. Prepare or submit or support other colleagues for Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices.
3. Responsible for training of site study team regarding the monitoring plan, recording & maintenance of essential documents and for start up activities & site initiation as per the guidance of Project Manager.
4. Maintaining a working copy of Central Investigator File & ensuring consistency with the Site Investigator File in order to maintain a working record of all essential documents and reports.
5. Ensure timely collection of documents like CRF, DCF etc from the site along with SAE reports in order to provide Biometrics/licensing authority & others with the necessary documents.
6. 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.
7. Responsible for site-closeout & follow up activities in order to maintain documents at the site.
2. Prepare or submit or support other colleagues for Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices.
3. Responsible for training of site study team regarding the monitoring plan, recording & maintenance of essential documents and for start up activities & site initiation as per the guidance of Project Manager.
4. Maintaining a working copy of Central Investigator File & ensuring consistency with the Site Investigator File in order to maintain a working record of all essential documents and reports.
5. Ensure timely collection of documents like CRF, DCF etc from the site along with SAE reports in order to provide Biometrics/licensing authority & others with the necessary documents.
6. 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.
7. Responsible for site-closeout & follow up activities in order to maintain documents at the site.
If interested kindly send updated resume on careers@cliantha.in
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