Clinical Research Associate | GenomeWeb

Clinical Research Associate

Organization
Genomic Health
Job Location
Redwood City, California, United States, 94063
Redwood City, CA 94063
Salary
DOE
Benefits

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.

Job Description

REQUIRED

  • Minimum 1-2 years experience as a CRA or other related experience in the health care, biotechnology, diagnostics, or other relevant industry; related experience may include clinical trial assistant, project assistant, study assistant or study coordinator.
  • Demonstrated competence with Microsoft tools, specifically Word; Excel; PowerPoint; and Project;
  • Well-organized and detail oriented;
  • Strong oral and written communicator with ability to maintain open communication with internal employees, managers and customers as needed
  • Able to integrate and apply feedback in a professional manner
  • Able to prioritize and drive to results with a high emphasis on quality
  • Ability to work as part of a team

 

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