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Senior Clinical Trial Assistant

Employer
SonALAsense
Location
San Francisco, California, US
Salary
Competitive
Closing date
Jan 15, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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Organizational Overview:

SonALAsense is a clinical-stage company developing sonodynamic therapy (SDT) as a first-in-class, noninvasive drug-device combination for the treatment of recurrent glioblastoma multiforme, diffuse intrinsic pontine gliomas, and other deadly cancers. SDT utilizes MR-guided focused ultrasound (the device) in combination with SONALA-001 (a drug) to selectively target and kill tumor cells.

The Role:

SonALAsense is seeking a Senior Clinical Trial Assistant to play a key role on a highly dynamic cross-functional team. You will report to the Senior Director, Clinical Operations and you will be responsible for administrative support in the advancement of clinical trials as part of SonALAsense's Clinical Operations team from study start-up to study closure.

Key Responsibilities:
  • In collaboration with the Senior Director Clinical Operations and/or VP Operations, support the study operational strategies
  • Assist with budget monitoring, including invoicing and confirmation of vendor and site payments
  • Develop meeting agendas and track minutes and follow-up actions
  • Ensure eTMF oversight, including routine quality checks to maintain a complete and inspection-ready state
  • Support the EDC specification process and user acceptance testing of the clinical data base
  • Maintain a vendor and site contact list
  • Assist with resolving clinical data base questions and queries
  • Support the multifunctional team on special initiatives as needed with oversight from the Senior Director Clinical Operations
  • Create and improve business processes to ensure SonALAsense's successful growth
  • Assist with vendor oversight


Key Skills:
  • Excellent organization skills
  • Understanding of technical, scientific and drug development process
  • Experience multitasking and overseeing multiple projects at once
  • Strong written and oral communication skills with incredible attention to detail
  • Able to adapt to rapidly changing project needs
  • Track record of thinking outside of the box and challenging the status quo
  • Track Record of unrelenting dedication toward delivering results
  • Proven ability to communicate to all levels of an organization and collaborate cross-functionally


Requirements:
  • Minimum of 3 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company) or CRO
  • BA/BS in a clinical or scientific discipline
  • Additional experience in related fields or positions, some phase 1/2 Oncology and global clinical trial experience is a plus
  • Working knowledge of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, and drug safety


Work Environment:
  • SonALAsense is headquartered in Berkeley, CA.
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic and international travel may be required (10%)
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