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Illumina is seeking a Clinical Trials 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.
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
- 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. If you have a disability or special need that requires accommodation, please contact us at 858-246-8959. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf