Clinical Trial Assistant II, Clinical Operations

1 month ago
Job ID
2017-5099
US
Category
Clinical Operations
CA
Redwood City

Overview

The Clinical Trial Assistant II (CTA) at Genomic Health, Inc. (“GHI”) is responsible for assisting Clinical Operations personnel 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

·        Clinical Trial Assistant II skills:

o   Assist with studies per departmental standard operating procedures (SOPs);

o   Trial Master File maintenance;

o   Review of essential documents;

o   Schedule team / internal meetings, track attendance, and document meeting minutes;

·        Collect essential documents per departmental SOPs

·        Assist in the development and management of clinical trial timelines

·        Arrange site teleconference calls using Outlook and track attendance

·        Follow up on action items

·        Assist CTM with study start-up, monitoring, and closeout activities

·        Assist with Electronic Data Capture System (EDC)

·        Other responsibilities as assigned

Qualifications

REQUIRED

 

·        Bachelor’s degree in life sciences, scientific or other relevant discipline and 2 – 4 years of relevant experience in the health care, biotechnology or diagnostics industry; OR

·        High school diploma or Associate’s Degree and 3 – 5 years of related experience in the 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

Travel, Physical/Mental Demands and Work Environment

- Travel Requirements: Limited, <10%
- Standing or sitting for long periods of time may be necessary
- Use of computer and/or telephone for long periods of time may be necessary
- Considerable periods of time may be spent concentrating and or analyzing data
- At times, stress may be experienced   

Company Profile

Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer, one of the greatest issues in healthcare today. With its Oncotype IQ™ Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

 

Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential.  We value our employees and consider them an integral part of our company’s growth and success. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs.  To learn more about careers at Genomic Health visit: http://www.genomichealth.com/join_our_team

 

All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.

 

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