Principal Investigator
19 hours ago
Chennai
Overall responsible for the smooth, safe and timely conduct of the BA/BE studies and
clinical trials conducted in MTR
- Responsible for allotment of principal investigator / clinical investigator / medical
officers prior to each study conducted at MTR.
- Co-ordinate with other investigators for the preparation of study plan.
- Co-ordinate with study managers, project managers in planning & execution of the study.
- Responsible for review of study protocol, ICDs, study related documents and its approval
from IEC/IRB.
- Review the study report (clinical, bio-analytical, PK and statistical) as per the applicable
regulatory requirement like CTD, eCTD etc.
- Responsible to follow the declaration of Helsinki and ICH-GCP guidelines and
regulatory requirements in executing the study.
- Responsible for receiving, maintaining, usage and archival of all investigational products
as described in the protocol with regulatory norms and as per applicable SOPs.
- Responsible for monitoring study activities.
- Responsible to ensure that all personnel involved in the clinical study are adequately
trained on SOP's internal process as defined and regulatory requirements.
- Responsible for counseling and obtaining informed consent form from the volunteers for
participation in the study.
- Responsible for planning and scheduling of activities as per study plan.
- Experience- 2 - 5 Years- Salary- 7 Lac To 8 Lac P.A.- Industry- Manufacturing / Production / Quality- Qualification- Other Bachelor Degree- Key Skills- Micro Therapeutic Research Principal InvestigatorAbout Company
- Company NameMicrotherpeutic Research Labs Pvt Ltd
- About Company- Micro Therapeutic Research Labs Pvt. Ltd (MTRL) is a full service Clinical Research Organization that offers Bioavailability/Bioequivalence (BA/BE) services to Pharmaceutical and Biotechnology industry worldwide. Situated at Chrompet in Chennai, Tamilnadu. Micro Therapeutic Research Labs offers world class services that are truly customized for unique research requirements. At MTRL, we operate with state of the art research facilities, thereby reducing cycle times for customers and accelerating the delivery of life-enhancing drugs to the market.- Contact Person- Sudha Suresh- Mobile- 9322358366
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