Clinical Investigator

Job Description

Hiring !! About Quantys Clinical Pvt. Ltd. Quantys Clinical Private Limited (QCPL) is a Contract Research Organization (CRO) offering technology-driven clinical research services to the pharmaceutical and nutraceutical industries. Established in April 2016, the company is located in Kandla SEZ (KASEZ), Gandhidham, Gujarat, with a facility covering 40,000 sq. feet. QCPL focuses on providing world-class services in bioequivalence testing and clinical trials, and also offers bioanalytical, pharmacokinetic, and statistical support. Position: Clinical Investigator Qualifications required: MBBS Experience: 1- 4 years. Job Location: Gandhidham (Gujarat). Roles and Responsibilities: 1. Medical screening of volunteers for registration 2. Compiling the medical examination of volunteers with clinical investigations lab reports for certifying the health status. 3. Perform medical examination of subjects during check-in and check-out phases 4. Clinical management of adverse drug reactions and adverse events 5. To assist principal investigator in the clinical conduct of the study as per protocol 6. Review of clinical raw data and report 7. Review and Writing of SOPs. 8. Clinical feasibility evaluations of conducting BE study for Sponsor interested molecules. 9. Propose study designs, Reviewing and finalizing Protocol, ICFs and CRFs prepared as per regulatory requirements in congruence with Sponsor requirements. 10. Obtaining the sponsor signatures and finalizing other study related documents and making the IEC submission for getting timely approvals from the IEC. Follow up with IEC for early and timely approvals or query resolutions. 11. Receiving Investigational products from the sponsor after approval of Protocol by the IEC and the DCGI. 12. Review of Screening lab reports and Post study lab reports along with the evaluations. 13. Correspondence with sponsor, IEC and DCGI. Responding to queries/ inquiries after internal discussions. Interested candidates can send their updated cv at hr@quantysclinical.com Show more Show less