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Job Title: Clinical Trial Specialist/Sr. Clinical Trial Specialist
Description:
Responsible for providing operational support for day-to-day execution of clinical trials. Follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities. Proactively identifies and resolves/refers operational project issues and participates in process improvement initiatives as required.
Ensures timely and accurate study-related communication to clinical personnel (i.e., internal and external study teams, consultants and investigative site personnel): Prepares and disseminates clinical trial correspondence and newsletters, IND Safety Letters (working with project clinician), and assists with creation of study-specific manuals, tools, and templates; coordinates specified clinical trial meetings (e.g., investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes.
Sets-up, tracks, and maintains audit-ready clinical trial documentation and study status in clinical trial management system: Manages and tracks regulatory/IRB/EC/REB documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings.
Qualifications:
Bachelor's degree or equivalent combination of education/experience in science or health-related field required. Clinical trial, study coordinator, data management, site monitoring and/or nursing experience preferred. Understanding of GCPs and knowledge of regulatory requirements preferred.
Compensation:
Commensurate with experience
Date Posted: 11/09/2007
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
