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Clinical Study Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2388283 |
| Location: Honolulu, Hawaii |
Date Posted: 7/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6720961 |
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Job Description:
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.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. Communicates with Investigators and Clients accordingly regarding participant eligibility. Works with team members to ensure staff, supplies and equipment are appropriate for the trial.Coordinates CRF activities as appropriate; ie: Oversees the completion of case report forms, CRF documentation and data queries. Works with the key staff to ensure that these items are completed in a timely manner. Oversees the transfer of CRF information to appropriate data management individuals.
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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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Web Site: http://www.biotechcrossing.com
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