The Clinical Research Associate (“CRA”) at Genomic Health, Inc. (“GHI”) is responsible for supporting the management of studies and projects for the development and commercialization of novel assays which lead to improved treatment decisions for patients. This position will also support investigator and other collaborative studies for the ultimate use of the commercial assays in facilitating treatment decisions for patients.
This position in Clinical Operations will report to a Clinical Trial Manager within the department.
Provides support to the management of clinical trials, including but not limited to:
· Participate in departmental or interdepartmental projects and initiatives under general supervision, such as, attending study team meetings, communicating with sites, track, monitor, and follow up on contracts, budgets, IRB submissions, etc.
· Provides assistance to the clinical trial manager in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
· Maintain study, program, and department documents with accuracy and timeliness using Microsoft Office programs (Word, Excel and PowerPoint).
· Works closely with the Clinical Trial Assistant (CTA) to supervise Trial Master File (TMF) filing and review, and audit readiness.
· Under supervision, may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and Clinical Study Reports (CSR'S)Contributes to SOP development on an as needed basis.
· Helps resolve routine study monitoring issues
· Monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents and files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
· Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions.
· Other duties and project support as assigned.