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| Job #02566 |
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| About our client |
| A global CRO that serves the pharmaceutical, biotechnology and medical device industries, our client is built upon a strong foundation of clinical, process and systems expertise. They specialize in major therapeutic areas such as oncology and dermatology. The company has supported more than 51 FDA approvals to date, with no refusals among submissions accepted for filing. |
| Position |
Location |
| Regional Clinical Research Associate (Home-Based) |
California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Manage the implementation and conduct of study protocols at research sites 2) Perform monitoring visits, including site qualification, initiation, monitoring and close-out visits 3) Maintain regular contact with study site to ensure protocol/GCP compliance 4) Participate in investigator meetings and other study training meetings as required 5) Prepare and participate in sponsor and FDA audits 6) Act as a mentor to junior staff 7) Work with minimal supervision |
| Requirements |
1) BS in scientific discipline/BA or equivalent combination of education and experience in a medical or scientific discipline 2) 3+ years of experience 3) Minimum 2+ years of experience in field monitoring with a CRO or other 4) clinical research setting 5) Experience in oncology preferred 6) Strong understanding of medical terminology, physiology and pathophysiology 7) Working knowledge of Good Clinical Practices 8) Ability to multi-task and work effectively in a fast-paced environment 9) Strong organizational, diplomatic and communication (oral and written) skills 10) Strong professional demeanor and appearance 11) Willingness to travel (75 – 85%) |

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