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Clinical Study Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2451870 |
| Location: Honolulu, Hawaii |
Date Posted: 8/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 7654597 |
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Job Description:
The Clinical Study Manager I has overall responsibility for the scientific and operational conduct of the studies allocated to him/her, under the auspice of a preceptor. The Clinical Study Manager I must ensure that all studies are conducted in accordance with Federal, state and protocol requirements, standard operating procedures, Good Clinical Practice and Covance standards of Good Laboratory Practice (GLP) as appropriate. The Clinical Study Manager I is the primary client contact and ensures that client requirements are met as well the safety and integrity of the study participants is maintained.Serves as the primary point of contact under the guidance of a preceptor, for the client for issues related to trial conduct. 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 IRB meetings, as appropriate.Submits revised protocol documents, amendments, study updates etc to the IRB office as appropriate for timely review
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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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