Clinical Research Coordinator
Winston Medical Staffing
Job Description
Job Description
Top NJ firm is looking for a detail-oriented Regulatory Coordinator Assistant to manage the regulatory side of its oncology/hematology clinical trials, from study start-up to close-out.
What you’ll do:
- Prepare and submit regulatory documents (protocols, amendments, ICFs, IRB start-ups and renewals, SAEs, deviations, SUSARs) to sponsors and IRBs
- Keep ISFs/regulatory binders and essential documents compliant with ICH-GCP and FDA requirements
- Schedule and support site initiation, monitoring, and close-out visits
- Review source documents and CRFs for accuracy, and follow up on monitor findings
- Work with sponsors, IRBs, and the clinical trial team
What you bring:
- 1+ year of experience in clinical trials, regulatory affairs, or oncology
- Knowledge of GCP, ICH, FDA, and EMA regulations
- Experience with eRegulatory, CTMS, EDC, and OncoEMR (a plus)
- Strong attention to detail and multitasking skills
- High school diploma required; associate degree preferred
Vacancy posted 2 days ago
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