Clinical Trial Specialist II
Remote · United States
Job Summary
Clinical Trial Specialist II at UBC focuses on end-to-end site management and regulatory compliance within clinical trials. Responsibilities include investigative site recruitment/feasibility, site training, remote clinical data monitoring and resolution, site progress tracking, in-house site management, essential document review and submission for regulatory and IRB requirements, management of site relationships, contract and budget negotiations, TMF preparation and audit readiness, and remote monitoring activities. The role requires leadership and mentorship of CTS staff, escalation of risks, and collaboration with Sponsors and Internal teams. Qualifications include a Bachelor's degree (or equivalent experience), 2+ years in clinical research, strong communication, and proficiency with Microsoft Office; familiarity with FDA/ICH-GCP, IRB processes, regulatory documentation, and CTMS is expected. The posting notes remote work opportunities and a comprehensive benefits package.
Required Qualifications
- Bachelor's degree or relevant work experience required
- 2+ years of relevant clinical research experience required
- Excellent written and verbal communication skills required
- Strong Microsoft Office skills (Outlook, Word, and Excel) required
- Aptitude in learning new computer systems required
- Ability to be flexible and multitask required
- Basic medical terminology or knowledge desired
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