Clinical Trials Associate II - 7860BR

Organization
Illumina, Inc.
Job Location
San Diego, CA 92101
Job Description

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

Illumina is seeking a Clinical Trial Assistant who will be an integral team member in the Clinical Affairs organization, a team responsible for integrating genetic, medical and laboratory principles to the application of clinical genome sequencing. This group will play a critical role in bringing genome sequencing to physicians as a tool for improving patient care.

The Clinical Trials Assistant will provide support for diagnostic product development to achieve clearances and approvals in the US and internationally. The role will provide support for clinical development activities consistent with applicable regulations, guidelines and procedures and may be responsible for supporting multiple clinical studies.

Responsibilities

  • The Clinical Trial Assistant’s responsibilities include (but are not limited to) the following:
  • Meeting scheduling and logistics (including call/web conference activation, resolution of technical issues)
  • Distribution of agendas and generation of meeting minutes
  • Study file maintenance (electronic and/or hard copy)
  • Document tracking and signature/approval follow-up, where applicable (including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation required in the study file)
  • Creating and maintaining study/project contact lists and tracking tools for budget, enrollment, samples, site supplies, and other study specific needs
  • Maintaining study timelines in MS Project
  • Study Regulatory Binder design, development, production and distribution (including study specific form creation)
  • Microsoft Office support for study, program, and department documents (Word, Excel and PowerPoint)
  • Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions
  • Other duties and project support as assigned
  • General administrative support to the Clinical Project Teams
  • Assist project teams with study specific tasks
  • All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Requirements

  • Bachelor’s degree or equivalent in the life sciences or related field required
  • 1-2 years of relevant work experience in health care, biotechnology or diagnostics
  • Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
  • Demonstrated ability to work independently and in a team environment
  • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, and Project)
  • Excellent oral and written communication skills, and strong organizational abilities
  • Travel required <20%

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.4 billion in 2016. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its “World’s Smartest Companies” list each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.

How to Apply

To apply for this position, please use the following URL:

https://ars2.equest.com/?response_id=037f10aee5db1ce720591a7d13c03d36

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