Nicole Stahl
Senior Clinical Research Specialist @Imricor
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WORK HISTORY
Senior Clinical Research Specialist @Imricor
Prepare clinical protocol, clinical brochure, case report forms, informed consent, and other required documents for clinical studies. Identifies and qualifies clinical investigators and clinical sites• Responsible for preparing clinical research reports and presents progress reports to keep management and team informed• Monitors clinical studies, ensuring site compliance with the clinical protocol and regulatory guidelines, assures subject safety, and ensures data integrity through completeness and accuracy• Actively participates as a member of cross functional project teams. Participates in assessing performance data generated by R&D prior to initiation of the clinical study.• Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.•Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory, Quality, Clinical, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.•Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
EDUCATION
University of Minnesota-Twin Cities
Bachelor of Science (B.S.), Statistics
ABOUT NICOLE STAHL
Senior Clinical Research Specialist at Imricor Medical Systems
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