Medical Investigator-Clinical Research(BA,BE Studies)- Vimta Labs Ltd

Job Description

Role & responsibilities : Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) are followed. 2. Conduct planned studies as per protocol requirements, quality system procedures and SOPs. 3. Review of pre study health records. 4. Obtain written informed consent before each Volunteer participation in the trial. 5. Ascertaining that clinical data is complete, accurate and is recorded as per protocol and SOP requirements. 6. Assessment and documentation of UDS reports & additional test reports. 7. Documentation of eligibility status. 8. Verification of daily Temperature log , Urotherm reading , Emergency medication kit documentation and expired medication discarding. 9. Briefing research staff on conducting the trail and Group briefing of ICF to volunteers 10. AE, SAE management, reporting and documentation. 11. Monitoring the trial throughout its duration. 12. Verifying the data entered on to the CRFs is consistent with source data. 13. ICU maintenance including management of emergency conditions. 14. Monitoring of Vitals documentation, ECG, Phlebotomy and X-ray procedures. 15. Verification of X ray films and X ray report destruction. 16. Post study reports assessments and documentation. 17. Completion status of CRFs and documentation. Secondary Responsibilities: 1. Review of ICFs, CRFs. 2. Screening and Evaluation of Volunteers for study participation. 3. Monitoring of drug administration to volunteers. Preferred candidate profile : Gender Preference : Male Industry : Clinical Research || BA, BE Studies Night Shifts : Yes No of Vacancies : 3 Contact : Ms Keerthana - 9160712930