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Clinical Trial Assistant

Apply Share Job ID 1206 Category Clinical Operations Job Location Redwood City, California Posted Date 12/10/2018

Overview:

The Clinical Trial Assistant I ("CTA") at Genomic Health, Inc. ("GHI") is responsible for assisting Clinical Operations team with studies to support the development and commercialization of novel genome-based assays, which lead to improved treatment decisions for patients with cancer.

This position reports to the Clinical Trial Manager or person assigned by the Director of Clinical Operations.

RESPONSIBILITIES / DUTIES:

· Assist with studies and support the logistical aspects of clinical trial conduct in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
· Maintain Trial Master File by setting up and using tracking tools
· Assist in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to SOPs and study requirements, as well as periodic review of study files for accuracy and completeness.
· Assist with review of clinical study data and essential documents for quality control purposes.
· Work closely with other members of the Clinical Team to support activities during a study startup, study execution and close out phases
· Facilitate and document the internal project meetings, draft internal and external correspondence and file the associated documentation; schedule team / internal meetings and track attendance
· Maintains knowledge of regulations, guidelines, policies, and practices for conducting clinical trials. ·
· Provide administrative support, may travels as required to carry out responsibilities
· Other responsibilities as assigned

QUALIFICATIONS:

REQUIRED

· Bachelor's degree in life sciences, scientific or other relevant discipline and up to 1 year of relevant experience in the healthcare, biotechnology or diagnostics industry;
· High school diploma or Associate Degree and 1 - 3 years of related experience in health care, biotechnology or diagnostics industry;
· Familiarity with applicable regulatory requirements, Good Documentation Practices, and Good Clinical Practices/ICH guidelines
· Demonstrated competency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and Project;
· Ability to work as part of a multifunctional team
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!