Clinical Research Scientist Job-Teva Pharmaceuticals

Location: Weston, Florida, USA

Company: Teva Pharmaceuticals

Job Position: Clinical Research Scientist 

JOB DESCRIPTION:

Qualification:

Education & Experience

1. Bachelors Degree in the field of Pharmacy, Chemistry, Biology, Health and Science or any related fields.

2. Experience conducting BE studies/clinical studies is preferred but not mandatory
3. Understanding of GCP, GLP and ICH guidelines and other guidelines applicable to conduct BE studies/clinical studies
4. Knowledge of basic statistical principles and their application to BE/PK studies
5. Basic computer skills
6. Good communication skills
7. Able to plan, organize, coordinate and manage tasks efficiently and independently

Job Responsibility:

1. Support generic product development from Weston, FL; other Teva development sites as required.

2. Evaluate the clinical studies required for generic products in development with the support of the Director and present the details, along with clinical background, in project kick-off meetings.
3. Attend team meetings and provide clinical support to the development team as needed.
4. Design (with the support of the Director) and coordinate BE studies according to current standards and guidance applicable to conduct of BE studies/clinical studies for US generic projects.
5. Prepare and maintain the Sponsor Trial Master File (TMF) for clinical studies for which the Clinical Research Scientist is the clinical study lead and to support other TMF activities within department if needed.
6. Review the clinical protocol and to review and approve Informed Consent Forms (IFCs) and Case Report Form (CRFs) for BE studies/clinical studies (with the support of the Director).
7. Work with the CRO to ensure that all deliverables are received as per the agreed upon timelines.
8. Compile information in support of Clinical Trial Applications (CTA) and Import License applications and to send them to the concerned Clinical Research Organizations (CROs).
9. Supervise and coordinate various study related tasks from study initiation to closure in compliance with clinical SOP/BPG requirements.
10. Arrange for handling, storage and retention of the Investigational Medicinal Products (IMPs), e.g. test and reference products.
11. Ensure that the IMPs intended for use in BE studies/clinical studies are labeled in accordance with Federal Regulations and local requirements where the study will be conducted.
12. Ensure timely shipping of the IMPs to the CRO/clinic site.
13. Ensure monitoring of BE studies as per SOP/BPG requirements.
14. Review clinical study reports.
15. Support the clinical team in Weston with various clinical operational activities as needed (shipping IMP to clinic, clinical labelling of IMP, TMF, etc.).