indeed
Clinical Research Associate
Charak Hospital & Research centre
Uttar Pradesh, IND
Full-time
Onsite
₹15,000–₹20,000 per month
Discovered 4 weeks ago
Clinical trial managementICH-GCPICMR Ethical GuidelinesNew Drugs and Clinical Trial RulesTrial Master File (TMF)Investigator Site File (ISF)
Key Skills for This Role
Clinical trial managementICH-GCPICMR Ethical GuidelinesNew Drugs and Clinical Trial RulesTrial Master File (TMF)Investigator Site File (ISF)
Full Job Posting
Clinical trial management
- Coordinate and manage all phases of hospital clinical trials according to protocol.
- Assist the Principal Investigator with feasibility assessment, site initiation, and trial execution.
- Conduct site monitoring visits, including SIV, SMV, SCV, and COV.
- Ensure accurate CRF/eCRF data entry and coordinate resolution of data queries.
Compliance and patient protection
- Conduct trials in compliance with ICH-GCP, ICMR Ethical Guidelines, and New Drugs and Clinical Trial Rules.
- Maintain confidentiality of research data and patient information.
- Recruit eligible patients or volunteers according to inclusion and exclusion criteria and obtain informed consent.
Documentation and coordination
- Maintain TMF, ISF, ICF, and CRF documents and prepare Ethics Committee submissions, approvals, amendments, and SAE reports.
- Coordinate regulatory approvals and renewals with DCGI/CDSCO and the Institutional Ethics Committee.
- Coordinate investigational product handling with doctors, nursing, laboratory, and pharmacy teams.
- Support research proposals, protocols, SOPs, staff training, monthly status reports, and enrollment logs.
Pay
- ₹15,000–₹20,000 per month.
Benefit
- Cell phone reimbursement.
Work location
- Work is in person.
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