Clinical Research Associate

Clinical Research Associate

Novartis Indonesia- Greater Jakarta Area, Indonesia

Job Description

Perform assigned activities to support monitoring of investigator sites and trial execution within the CPO under the supervision of ICRO management.

1. May 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 to trial site training activities, as assigned.
4. May perform monitoring visits according to monitoring plan, as assigned, including source document verification.
5. May facilitate site drug supply management.
6. Site level update of technical systems (ClinAdmin, EDC).
7. Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
8. Demonstrate and can apply GCP and ICH requirements.
9. May prepare study monitoring reports under supervision, as appropriate.
10. Assist with data query resolution process (both at Site and with Data Management).
11. Perform Site Closeout activities.

Desired Skills & Experience

- Education in a healthcare or scientific discipline, a nursing qualification or relevant experience working within the CPO Medical, Safety, or QA department.
- Fluent in English (oral and written)
- Demonstrates ability to coordinate, organize and communicate
- Basic understanding of clinical development process including GCP and ICH fundamentals.
- Proven ability to work on teams and deliver on commitments.
- Computer literacy
- Level of proficiency in adequacy with the CRA I competency profile.

Company Description

PT. NOVARTIS INDONESIA is an innovative multinational healthcare products company with pharmaceutical treatments for heart disease, high blood pressure, diabetes, Parkinsons, Alzheimers, infections disease and cancer, with about 550 employees in its Pharmaceutical and Consumer Health division including in its manufacturing plant. Nowadays, the Company is aggresively developing its business and invites qualified external canddidates to join the internal employees.

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