ResearchEd

Clinical Research

• Review, understand, and assess clinical data before Medical/Client review.
• Communicate and present relevant trends and findings to the Study Team and the Client.
• Ensure clinical database and regulatory projects (e.g., Clinical Study Reports) maintain the highest level of integrity.
• Collaborate with the Client, subcontractors, and Catalyst assigned Study Team members to meet project timelines and Client expectations.
• Assist in the review of CRFs, data quality review plans, and other clinical study reports.
• Partner with the Study Team in the development of data review plans for individual clinical studies and CRF design.
• Provide continuous review and interpret relevant clinical efficacy and safety endpoint data across listings and visual analytics.
• Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).
• Create data summary slides for Safety Review Committee Meetings, DSMBs, and Catalyst Data Review Meetings.
• Create queries on EDC data as needed during Clinical review, provide timely follow up and identify potential protocol deviations.
• Assist in the development of study-specific listings and perform informal UAT testing for project level Clinical analytic dashboards.
• Review and provide input on data driven sections of reporting documents, such as INDs, BLA/NDAs, Annual Report, IBs, briefing books, CSRs, IMPDs, etc.
• Mentor and/or train staff and provide scientific writing for subject/patient narratives or non-regulatory documents such as abstracts, posters, and oral presentations.
• Serve as point of contact for site staff and monitors regarding study protocol and clinical inquiries.
• Fluent in Visual Analytics interpretation.

Associate Clinical Scientist / Clinical Scientist