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| Job Location | Delhi |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Bio Tech / R&D / Scientist |
| EmploymentType | Full-time |
Clinical research associate Job Description 1. Act as monitor of specific sites on a clinical study, under supervision, as appropriate. 2. Facilitate preparation and collection of site level documents. 3. Participate in trial site training activities, as assigned. 4. Perform monitoring visits according to monitoring plan, as assigned, including source document verification. 5. Facilitate site drug supply management. 6. Co- ordinate site level updates of technical systems (ClinAdmin, EDC). 7. Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc). 8. Demonstrate and apply GCP and ICH requirements. 9. Prepare study monitoring reports under supervision, as appropriate. 10. Assist with data query resolution process (both at Site and in- house with Data Manage- ment). 11. Perform Site Closeout activities. 12. Under the guidance of Senior CRA/ CRA Group Head perform IM related activities like logistics, preparation of IM binders and technical presentations. 13. Assist with preparation of required regulatory submission liaising with DRA team. Minimum requirements Education in a health care or scientific discipline, a nursing qualification or relevant experience working within the CPO Medical, Safety, or QA department. Fluent English (oral and written). 1. Demonstrates ability to coordinate, organize and communicate 2. Basic understanding of clinical development process including GCP and ICH fundamentals. 3. Proven ability to work in teams and deliver on com- mitments. 4. Computer literacy 5. Level of proficiency in adequacy with the CRA I com- petency profile.,
Keyskills :
documentationdracralinicalresearchstudymonitoringclinicaldevelopmentqueryresolutionconstructionplanningcomputerliteracyclinicalstudyclinicaltrials