A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : 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.
Candidate Profile
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.
Additional Information:
Job ID: 213052BR
Location: Mumbai
Division: Global Drug Development
Business Unit: GDO GDD
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Research & Development
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