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Lead Clinical Research Associate/ Clinical Trials Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2388276 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6731784 |
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Job Description:
Defines site qualification criteria and participates in or oversees the identification process of potential investigators and clinical sites; oversees and participates (as needed) in pre-study site visits, reviews evaluative reports; participates in the final selection of study sites. Defines the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with relevant internal departments (as necessary). Oversees and participates (as needed) in initiation visits, review of reports and follow-up to identify and resolve site issues. Participates in and/or may oversee Investigator Meetings. Study Interim Activities: Oversees the day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc). Identifies and evaluates issues related to the project and coordinates resolutions. Oversees and participates (as needed) in site monitoring visits, review of reports and follow-up to identify and resolve site issues. Ensures appropriate transmission of CRF data to data management team and reviews queries. Identifies data deficiencies and discrepancies, and coordinates corrective action as required. Oversees Serious Adverse Event reporting including documentation, tracking and follow-up. Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards. Study Close-Out Activities and Clinical Study Report (CSR) Writing Process: Oversees and participates (as needed) in site close-out visits, review of reports and follow-up to identify and resolve final site issues. Coordinates the interaction between the relevant parties in the database lock process. Participates in and coordinates the review and approval process of Tables, Listings and Graphs. Coordinates CSR writing, review and approval process including the compilation of all required sections. QUALIFICATIONS BS/BA/BSN - health related field preferred.
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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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