3 дня назад
Clinical Trial Associate (Early Phase)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Associate (Early Phase) (Clinical Operations): Supporting early-phase clinical trials across study start-up, maintenance, and close-out with an accent on Trial Master File management, study tracking, vendor coordination, and regulatory documentation. Focus on maintaining accurate study systems, coordinating cross-functional activities, and resolving operational issues in compliance with ICH-GCP and applicable regulations.
Location: Thousand Oaks, California or San Francisco, California, United States; hybrid or office-based expectations. Occasional travel may be required for study team meetings, vendor meetings, site visits, and other clinical trial activities.
Company
develops and sponsors clinical trials in the biotechnology and therapeutics space.
What you will do
- Support clinical trial start-up, maintenance, and close-out activities.
- Maintain electronic Trial Master Files, review filing quality, and track essential study documents.
- Maintain study trackers, contact lists, action-item logs, training trackers, vendor trackers, and SharePoint sites.
- Coordinate study meetings, investigator meetings, site training, vendor meetings, agendas, minutes, and follow-up actions.
- Support clinical trial systems, portals, document reconciliation, site correspondence, monitoring documentation, safety documentation, and vendor deliverables.
- Track milestones, deliverables, risks, issues, decisions, invoices, budgets, contracts, and work orders, escalating delays as needed.
Requirements
- Bachelor’s degree or equivalent, preferably in a scientific discipline or health-related field.
- At least 2 years of relevant industry experience and working knowledge of clinical trial conduct.
- Familiarity with ICH-GCP, CFR, and applicable clinical research regulations.
- Strong organizational, communication, prioritization, and issue-escalation skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, Teams, and clinical study systems.
- Ability to work from Thousand Oaks or San Francisco with hybrid or office-based expectations and occasional travel.
Nice to have
- Experience supporting Trial Master File activities.
Culture & Benefits
- Collaboration with clinical trial leads, cross-functional teams, vendors, and trial sites.
- Work across time zones with internal and external stakeholders.
- Exposure to early-phase clinical trial operations and regulatory inspection support.
- Hybrid or office-based work arrangement determined by business needs.
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