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Clinical Study Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2403394 |
| Location: Honolulu, Hawaii |
Date Posted: 7/29/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6720961 |
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Job Description:
As such the Clinical Study Manager I must maintain close liaison with the client on study status.Monitors participant safety and compliance, including coordination of appropriate medical consultation /treatment as appropriate. Provides updates regarding participants well being to the investigators and clients including AE updates etc.Keeps the client aware of deficiencies or potential problems and assists in taking appropriate action in response to these issuesEnsures that all studies are carried out in strict accordance with the relevant protocols, SOPs and the specified standard of the GCPs.Facilitates and coordinates client visitsAssists in communication with Client Services to obtain background information regarding the client and the study. Assists in coordination of timelines, goals, objectives and future activities. Ensures regulatory documentation is current and available for the trialEnsures that all necessary documents are approved by the IRB in a timely manner.Is fully aware of all regulatory submissions, timelines and approvals.Attends meetings, as appropriate.Submits revised protocol documents, amendments, study updates etc to the IRB office as appropriate for timely review.Ability to review and apply operational knowledge to the conduct of a protocol. Works with recruiting and screening staff to define a recruiting plan for the trial and to ensure that the study is recruited on schedule. Clients are regularly updated with recruiting and screening information, question and concerns. Reviews participant eligibility information to determine if protocol criterions are met.
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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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