Regulatory Analyst
October 8
Description
• Reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start-up through study closure • Maintenance of regulatory documents to ensure compliance with applicable requirements and regulations • Oversees and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance • Serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. • Submits or assists in the submission of applications for institutional clinical trials • Sends decision correspondence to appropriate parties, requesting information • Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance • Maintains current knowledge of applicable regulatory topics
Requirements
• Education: Bachelor's Degree in relevant field • Certification and Licensing: Not required, but recommended (e.g., SOCRA - CCRP) • Experience: Minimum two (2) years of relevant experience in fields such as compliance, research, and/or medical/clinical • IND/IDE/FDA experience preferred. • Ability to maintain effective interpersonal relationships • Ability to communicate effectively in both oral and written form • Ability to utilize sound judgment, analyze problems, provides solutions and makes decisions. • Skill in collecting, organizing and analyzing data. • Highly organized, proactive, and detail oriented • Excellent skills in time-management, prioritization, and multi-tasking • Proficiency in computer software (i.e., Microsoft Office, Adobe Acrobat) • Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers and clients. • Ability to analyze, organize and prioritize work under pressure while meeting deadlines. • Knowledge of processes associated with clinical trials • Knowledge of applicable federal, state, and local rules and regulations
Benefits
• Competitive salaries • Comprehensive benefits package including medical • Dental • Tuition remission • More
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