Sr. Clinical Research Associate
Verinata Health, an Illumina Company is dedicated to the development of non-invasive prenatal diagnostic tests. Our mission is to develop diagnostic tests that provide women, their families and healthcare providers with accurate and timely information about fetal and maternal health. We do this by developing and commercializing non-invasive and accurate prenatal diagnostic tests for use in early pregnancy, for all women.
Verinata Health is located in Redwood City, CA. We are looking for talented people with proven skills in their discipline who enjoy working in a collaborative environment to further advances in maternal and fetal health care. This opportunity to work within a small entrepreneurial team offers tremendous growth opportunities, with competitive benefits and compensation.
We are seeking a Sr. Clinical Research Associate who is highly motivated to join our efforts in bringing non-invasive prenatal diagnostics to market.
Able to independently manage the study start up activities for a multi-center, US based IVD study
Responsible for clinical site training and adherence of the site to protocol, applicable ICH/GCP guidelines, regulations, statutes, and SOPs.
Independently create project specific documents and tools – e.g., Monitoring Plan and Guidelines, meeting materials, tracking spreadsheets and databases, training tools, manuals, materials, etc.
Mentor and coach junior staff new to Clinical Research; CTAs
Assist with the development of new diagnostic studies, including protocol writing, informed consent development, monitoring plans, CRFs, tracking forms, and other study related documents
Conduct study qualification visits for the purpose of assessing the site’s ability to effectively conduct the trial per SOP and study guidelines.
Perform relationship management tasks (e.g., contracts, sample management, supplies, etc.) and evaluate CRO performance
Other duties and assignments as needed for the overall success of studies
Strongly prefer RN. Will consider BS/BA.
Must have with at least 5 years clinical trial monitoring experience in accordance with CFR, GCP and ICH Guidelines.
Prefer OB and diagnostic experience.
Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language
Experience managing sites in large, multi-site clinical studies
Ability to travel, as required (up to 40%)
Illumina Inc is an equal opportunity employer.
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