Associate Clinical Operations
Job Summary
Supporting clinical research studies remotely, the full-time Associate Clinical Operations will manage sponsor, site, and vendor relationships while overseeing studies from startup through closeout.
Key responsibilities
- Manage relationships with sponsors, sites, and vendors throughout the study lifecycle
- Participate in protocol design discussions and develop operational documentation, including IRB submission packages
- Lead Site Initiation Visits (SIVs) and support training for sites and central raters
Required qualifications
- Undergraduate degree or equivalent professional experience
- Experience operationalizing clinical study protocols and managing multiple research projects
- Professional background in biotech, pharmaceutical, CRO, clinical site, or consulting environments
- Knowledge of GCP, ICH, HIPAA, GDPR, FDA requirements, and clinical research regulations
- Working knowledge of EDC, ePRO, EHR, and clinical research technologies
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