Clinical Trial Associate

Responsibilities:
- Develop and maintain study tools and trackers (e.g., contact lists, vendor contract tracking, site visit report completion, sample management)
- Update clinical study and portfolio overview reports for senior management
- Route and track approvals for essential study documents (e.g., informed consent, study plans)
- Submit and track study agreements, contracts, and budgets
- Obtain/assign investigative site identification numbers
- Request country-level clinical trial liability insurance certificates
- Provide Regulatory Affairs with 1572/Investigator Statement of Compliance and Financial Disclosures
- Request study set-up in Veeva Vault and system access for study team members
- Collaborate on eTMF Plan and Expect Document Lists (EDLs); support TMF filing and reconciliation activities
- Assign and track study-specific training; manage off-site document storage/retrieval
- Support clinical trial registration (e.g., ClinicalTrials.gov) and execute ad hoc administrative tasks
- Assist with meeting logistics, agendas, minutes, and materials; support SOP/WI updates

Requirements:
- Strong organizational skills and attention to detail
- Ability to multitask and prioritize; excellent written/verbal communication
- Ability to work independently and collaboratively
- Basic software skills (MS Outlook, Word, Excel, DocuSign)
- Proficiency in Veeva eTMF
- Basic GDP and ICH-GCP understanding; identify/categorize essential TMF document types (ICH E6)
- Critical thinking skills

Preferred:
- 4-year college degree
- At least 1 year in a similar industry role

Benefits/Pay:
- California pay range: $60,000–$80,000 USD; competitive salaries and an excellent benefit package.

Application instructions:
- Must have current, valid authorization to work in the country where the role is located.