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| Job #03066 |
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| About our client |
| Our client is an international CRO that provides full-service clinical trials management support for various therapeutic areas, such as oncology and cardiology. Their vision is to become the preferred CRO for life science companies across the world. This is a great opportunity for someone looking for growth and an exciting challenge! |
| Position |
Location |
| Clinical Research Associate |
San Diego, California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Prepare and execute clinical investigations
2) Oversee all aspects of study monitoring for CROs
3) Participate in investigator site selection
4) Coordinate vendor/CRO services
5) Initiate, review and negotiate site budgets/contracts
6) Participate in and handle the organization of sponsor and investigator meetings
7) Review, revise and develop SOPs
8) Schedule and monitor clinical investigational sites
9) Design/prepare CRFs
10) Generate study specific monitoring plans and informed consent templates
11) Prepare clinical study supplies to be shipped to the investigational sites
12) Monitor CRO activites in overseas markets like India |
| Requirements |
1) RN or BSN (Nursing), BS or BA in Life Sciences, Pharmacy or Medicine
2) 2+ years of progressively increasing clinical research experience (in the pharmaceutical industry)
3) Experience in a small biotech environment preferred
4) Experience in organizing and the administration of early stage (Phase I or Small Stage II) and late-stage clinical trials a plus
5) Experience in drug development (FDA regulations, GCPs or Associates of Clinical Pharmacology CRA certification)
6) Experience in supporting business development efforts, specifically in offshore locations like India
7) Ability to resolve and make judgments regarding administrative, scientific and/or clinical problems under supervision
8) Ability to prepare summary reports as well as deliver clear and concise presentations |
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