Urgent Opening for Clinical Research Associate @ Karmic Lifesciences LLP
Job Description
Job Responsibilities:
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
Act as Lead Monitor, maintain contact with site personnel and ensure timely resolution for study specific queries as well as proper escalation of site/project related issues to sponsor
Maintain audit readiness at the site level for any audits or regulatory inspections
Conduct site/study close-out activities and assure appropriate archival of controlled documents and retrieval of CRFs, Clinical Supplies and other relevant study materials
Compile and review weekly and monthly project metrics relating to study conduct e.g. Patient Screening, Recruitment & Drop-outs, Subject Logs, Safety Logs, CRF Retrieval status etc.
Manage and provide oversight to New Study Feasibilities including site feasibilities and qualification
Salary: As per industry standards
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other
Role Category:Other
Role:Other
Keyskills
Clinical Research Associate Clinical Monitoring Clinical trial
Desired Candidate Profile
Education-
UG: Any Graduate - Any Specialization, B.Pharma - Pharmacy
PG:Any Postgraduate - Any Specialization
Doctorate:Doctorate Not Required
We have an urgent opening for Clinical Research Associate, wherein we are looking out candidates with min 1 to 2 years of experience in clinical trial monitoring.
Below are the requirements:
Candidate should have capability to work under tight timelines.
Decent communication skills
Clinical trial experience
Interested candidates can send us your updated resume at hr@karmiclifesciences.com.
Company Profile:
Karmic Lifesciences LLP
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.
Click here to apply
Job Description
Job Responsibilities:
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
Act as Lead Monitor, maintain contact with site personnel and ensure timely resolution for study specific queries as well as proper escalation of site/project related issues to sponsor
Maintain audit readiness at the site level for any audits or regulatory inspections
Conduct site/study close-out activities and assure appropriate archival of controlled documents and retrieval of CRFs, Clinical Supplies and other relevant study materials
Compile and review weekly and monthly project metrics relating to study conduct e.g. Patient Screening, Recruitment & Drop-outs, Subject Logs, Safety Logs, CRF Retrieval status etc.
Manage and provide oversight to New Study Feasibilities including site feasibilities and qualification
Salary: As per industry standards
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other
Role Category:Other
Role:Other
Keyskills
Clinical Research Associate Clinical Monitoring Clinical trial
Desired Candidate Profile
Education-
UG: Any Graduate - Any Specialization, B.Pharma - Pharmacy
PG:Any Postgraduate - Any Specialization
Doctorate:Doctorate Not Required
We have an urgent opening for Clinical Research Associate, wherein we are looking out candidates with min 1 to 2 years of experience in clinical trial monitoring.
Below are the requirements:
Candidate should have capability to work under tight timelines.
Decent communication skills
Clinical trial experience
Interested candidates can send us your updated resume at hr@karmiclifesciences.com.
Company Profile:
Karmic Lifesciences LLP
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.
Click here to apply
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