Clinical Research Associate

Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

23andMe is looking for a clinical trial or clinical research associate to support our Clinical Operations Team.

What You'll Do

• Assist with the development of tracking tools and processes; maintain study tracking information, including monitoring visit reports, patient enrollment, study contact lists, etc.
• Facilitate creation of meeting agendas and take meeting minutes for Study Management Team meetings; manage the study Action Decision Issue (ADI) log
• Support achievement of study milestones through close collaboration with the Clinical Trial Manager and cross-functional colleagues
• Assist with study start up and related activities
• Participate in the review of clinical data in the EDC, data listings, and report tables
• Conduct systematic quality review of the TMF and work to resolve discrepancies
• Communicate effectively with internal and external cross-functional team members
• Track vendor shipments (eg. laboratory samples and ancillary supplies), as needed
• Liaise with CRO, third-party vendors, and clinical sites to resolve issues, as required
• Coordinate preparation of study-specific training materials, as required
• Assist with essential document development and finalization, including informed consent forms (ICFs), patient and site materials, study plans and manuals, protocols/protocol amendments, as required
• Assist with the development of study vendor systems including specification review, user acceptance training, and creation of forms and manuals
• Assist with drafting and review of submissions and responses to ethics committees and IRBs
• Draft internal communication tools such as study dashboards for dissemination to the broader team
• Develop and maintain study registry postings
• Complete other responsibilities as assigned and agreed upon

What You'll Bring

• Bachelor's degree to equivalent training and experience (i.e. technical degree)
• CTA: 1+ years experience in clinical operations (relevant experience may be at the clinical site or Sponsor; oncology experience desired)
• CRA: 2 - 3+ years experience in clinical operations (relevant experience may be at the clinical site or Sponsor; oncology experience desired)
• Strong attention to detail and excellent organization skills
• Effective communication, interpersonal skills and team player
• Proficient in Google Suite, Office Suite, Smartsheet
• Location: SSF (Hybrid). Travel not anticipated.

About Us

23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company's mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world's largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.

At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual's race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at accommodations-ext@23andme.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.

Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.