Research Regulations Specialist oversees the daily regulatory activities for research studies and coordinates and performs administrative research protocol support services. The Research Regulations Specialist assists in the creation, maintenance and utilization of databases containing clinical, financial, and other outcome data.
Coordinates and prepares documents for implementation of clinical trials including:
Publishes and distributes information to all sub-investigators notifying them studies open for enrollment. Develops study summaries for sub-investigator education.
Maintains internal and external databases as assigned.
Coordinates and prepares for monitoring visits for industry-sponsored studies and audits.
Maintains spreadsheet for tracking incoming related to research activities.
Compiles accrual data for protocols, reviews and summarizes information for research team, Institutional Review Boards and local hospitals as needed for their reports.
Prepares agenda for monthly local IRB meetings to submit new studies, annual reviews, amendments and modifications.
Prepares necessary forms for the FDA Investigation of New Drug applications; submits Adverse Events and Safety Reports to Institutional Review Board; submits UI Laboratory Certification forms and all other regulatory request to sponsors and National Cancer Institute, submit detailed letters of correspondence to the Institutional Review Board.
Assures appropriate routing procedures and signature approval requirements are met for industry and National Cancer Institute sponsored budgets and grants.
As appropriate, develops and maintains tracking databases to assure timely reporting of required documents to regulatory bodies and study sponsors. Ensures accurate and timely data collection and entry into databases as indicated by department guidelines.
Prepares clear, concise, attractive reports using spreadsheets, word processing, graphic and presentation software as
Participates in the development, implementation and evaluation of policies and procedures.
Commitment to co-workers
Establishes professional competence through the processes of continuing education, professional organization involvement and in services.
Performs other duties as assigned.