Company Description|Job Description
ABOUT OUR COMPANY
Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
TheClinical Trial Assistant (CTA)is 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:
- File, track & maintain study activity within the Clinical Trial Management System (CTMS)
- Managethe electronic Trial Master File (eTMF) to meet ICH/GCP requirements & work in conjunction with Clinical Trial Mangers to create & execute on study-specific TMF Plans
- Prepare study related materials for the training of internal & external staff
- Coordinate execution of Non-Disclosure & Confidentiality Agreements (NDAs) with study sites
- Review regulatory packets for completeness & accuracy
- Assist clinical teams with study supplies management
- Prepare & distribute Investigator Site Files (ISFs)
- Track 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), & coordination of travel arrangements, dinner reservations, car service, off-site meeting rooms)
- Track & collate clinical trial documentation related to Clinical Study Report (CSR) appendices
- Support quality review of electronic Case Report Forms (eCRFs)
- Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
- Previous experience with Veeva CTMS/eTMF is highly preferred
- Good interpersonal/communication skills
- General knowledge of computers & navigating databases
- Well organized, team-oriented individuals encouraged to apply
- Bachelor's Degree in biology-related field or equivalent healthcare or laboratory-related work experience
- At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) is preferred
All your information will be kept confidential according to EEO guidelines.
This description is used as a guideline for major duties. The company reserves the right to change or assign additional duties as needed.