Clinical Research Associate
Posted on 3/20/2023
INACTIVE
Personal genomics & biotechnology company
Company Overview
23andMe’s mission is to help people access, understand, and benefit from the human genome. The company has created the world’s largest crowdsourced platform for genetic research and is the only company with multiple FDA authorizations for genetic health risk reports. The company is also in development of discovery programs rooted in a diverse spectrum of human genetics to ultimately deliver reports and results from all spectrums of your DNA.
Biotechnology
Company Stage
N/A
Total Funding
$1.2B
Founded
2006
Headquarters
Sunnyvale, California
Growth & Insights
Headcount
6 month growth
↓ -1%1 year growth
↓ -2%2 year growth
↑ 16%Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Biology & Biotech
Requirements
- 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
Responsibilities
- 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