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Manager, Clinical Research Associates Job
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| Employer Name: BiotechCrossing |
SpiderID: 2221073 |
| Location: San Jose, California |
Date Posted: 5/12/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
The CRA Manager reports to the Director, Clinical Operations, and has responsibility for leading the CRA function (protocol, monitoring, reporting of Clinical studies within Clinical Operations. Plays a critical role in ensuring that studies conducted by Clinical Operations are appropriately monitored to ensure adherence to all relevant SOPs, thereby ensuring the credibility and rigor of the studies. Maintains study schedules, resource needs, and other key elements, and works closely with the Director, Clinical Operations; Manager, Clinical Project Leads, CRAs; Clinical Data Management, and Statistics, to ensure the optimal timing, coordination and execution of studies. Leads a staff of CRAs in managing clinical studies to assure adherence to intended timelines including protocol development, site qualifications, initiations, subject enrollment (if applicable), study closures, clinical study supplies, CRF data and other document deliverables, and verifying clinical study payments, and final report. Collaborates with key stakeholders (Clinical Project Lead, Regulatory, Marketing, Statistics, Research and Development), in order to develop and execute clinical studies. Participates in site qualification, monitoring and other CRA duties as needed. Accountable for ensuring that BDB clinical trials meet the highest standards for scientific quality, integrity, and ethics, and adhere to all applicable regulations and guidelines. Coordinates staffing and resources to ensure satisfactory support for ongoing projects and initiatives.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.biotechcrossing.com
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