Opening for Life sciences candidates as Clinical Research Associate Posts @ Karmic
Founded in 2005, Karmic Lifesciences an ICH-GCP compliant, full-service Contract Research Organization in Mumbai. Karmic has a 9 year successful track record of executing 150+ Clinical Trials and 75+ Clinical Data Management & Bio-Statistics Projects (Phase I to IV) in various therapeutic areas including Oncology, Cardiovascular, Diabetes, Neurology, Auto-Immune Diseases, Ophthalmology, and Medical Devices.
Job Title : Clinical Research Associate
Qualification : B.Sc/ M.Sc LifeScience
Experience : 2-4 years
No of posts : 2
Job Description :
Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and SOP training at sites, demonstrate study procedures including Source Templates Filing, Annotated CRFs & CRF filling instructions (Paper/EDC), Informed Consent procedures, Patient Screening & Eligibility procedures, IP Handling procedures, Safety Reporting & Unblinding procedures etc. to investigators and CRCs, ensure timely SIV reporting & follow-up letters
Conduct routine Site Monitoring Visits (SMV) to clinical sites, do Source Doc Verification, review Site Master Files (SMFs), relevant study and patient records, resolve open site issues, ensure timely SMV reporting and follow-up letters
Verify Clinical Supplies Inventory and IP Management procedures at site and ensure complete and accurate drug accountability
Ensure Protocol Compliance in execution of trials, identify, document and resolve protocol deviations and violations, informed consent deviations and issue/action log
Ensure compliance to ICH-GCP, Indian GCP / Schedule Y and other applicable regulatory standards
Review communication of site with IRB/EC and other regulatory bodies
How to Apply :
Interested Candidates send your resume to : hr@karmiclifesciences.com
Click here to like our fb page
Founded in 2005, Karmic Lifesciences an ICH-GCP compliant, full-service Contract Research Organization in Mumbai. Karmic has a 9 year successful track record of executing 150+ Clinical Trials and 75+ Clinical Data Management & Bio-Statistics Projects (Phase I to IV) in various therapeutic areas including Oncology, Cardiovascular, Diabetes, Neurology, Auto-Immune Diseases, Ophthalmology, and Medical Devices.
Job Title : Clinical Research Associate
Qualification : B.Sc/ M.Sc LifeScience
Experience : 2-4 years
No of posts : 2
Job Description :
Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and SOP training at sites, demonstrate study procedures including Source Templates Filing, Annotated CRFs & CRF filling instructions (Paper/EDC), Informed Consent procedures, Patient Screening & Eligibility procedures, IP Handling procedures, Safety Reporting & Unblinding procedures etc. to investigators and CRCs, ensure timely SIV reporting & follow-up letters
Conduct routine Site Monitoring Visits (SMV) to clinical sites, do Source Doc Verification, review Site Master Files (SMFs), relevant study and patient records, resolve open site issues, ensure timely SMV reporting and follow-up letters
Verify Clinical Supplies Inventory and IP Management procedures at site and ensure complete and accurate drug accountability
Ensure Protocol Compliance in execution of trials, identify, document and resolve protocol deviations and violations, informed consent deviations and issue/action log
Ensure compliance to ICH-GCP, Indian GCP / Schedule Y and other applicable regulatory standards
Review communication of site with IRB/EC and other regulatory bodies
How to Apply :
Interested Candidates send your resume to : hr@karmiclifesciences.com
Click here to like our fb page
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