Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time & identifies associated treatment options. The assay is used by more than 6,000 oncologists & we partner with more than 50 biopharma companies.
Guardant Health raised over $550M from Sequoia Capital, Khosla Ventures, Lightspeed Ventures, OrbiMed & Softbank, before having a successful IPO on NASDAQ in 2018. Guardant is led by a seasoned management team of thought leaders & successful serial entrepreneurs in next generation sequencing & rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.
TheClinical Trial Operations Internis primarily responsible for the coordination of activities associated with the setup & management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects & general office work.
PRIMARY DUTIES & RESPONSIBILITIES:
- Support management of the Trial Master File (TMF) to meet ICH/GCP requirements & work in conjunction with Clinical Trial Mangers & Clinical Trial Assistants to create & execute on study-specific TMF Plans
- Prepare study related materials for the training of internal & external staff
- Review regulatory packets for completeness & accuracy
- Assist clinical teams with study supplies management
- Prepare & distribute Investigator Site Files (ISFs)
- Assist with tracking departmental payments & vendor invoices
- Conduct study tracking activities (sites status, reconciliation activities, filing & archiving)
- Assist with meeting coordination: scheduling meetings, meeting agendas, meeting minutes, & meeting materials (creating PowerPoint Presentations as directed by senior team members)
- Track & collate clinical trial documentation related to Clinical Study Report (CSR) appendices
- Support quality review of electronic Case Report Forms (eCRFs)
Knowledge, skills & abilities:
- Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
- Good interpersonal/communication skills
- Detail oriented
- Well organized, team-oriented individuals encouraged to apply
- General knowledge of computers & navigating databases
Minimum certifications/educational level:
- Bachelor's Degree candidate in biology-related field or equivalent healthcare or laboratory-related work experience