Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
About the role
- Senior Clinical Study Manager supporting Medical Division with clinical studies to enable market access for medical devices. Ensuring compliance and overseeing operations for clinical evidence gathering.
Responsibilities
- Manage day-to-day operations of one or more clinical studies, ensuring compliance with GCP, FDA regulations, and internal procedures.
- Develop and maintain study-specific documents, including protocols, amendments, monitoring plans, and operational guidelines.
- Oversee data collection, validation, and documentation to meet quality standards and timelines.
- Coordinate and support field-monitoring activities; track enrollment curves and study milestones.
- Assess project risks and implement mitigation strategies to ensure deliverables are achieved.
- Initiate and manage research contracts for Investigator-Initiated Studies and ensure alignment with research strategy.
- Drive publication of study results in peer-reviewed journals by collaborating with internal and external stakeholders.
- Maintain dashboards for clinical and non-clinical studies, tracking objectives, timelines, and financial aspects.
- Oversees clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).
- Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence.
Requirements
- Bachelor’s degree, preferably with Health Sciences or related technical field
- 6+ years of relevant clinical research experience, preferred in clinical study management
- Medical device experience
- Advanced degree (MSc, PhD) in health sciences, biomedical engineering, health outcomes research
- Preferred clinical research or project management certification
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
- bonuses
Job title
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Degree requirement
Tech skills
Location requirements
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