Regulatory Analyst
5 days ago
Description
• Reviews, prepares, and provides oversight for regulatory submissions from study start-up through closure • Maintains regulatory documents to ensure compliance with applicable requirements and regulations • Oversees study submissions (initial and amendment) and regulatory document maintenance • Serves as point of contact for various boards, committees, and sponsors • Submits or assists in submission of applications for institutional clinical trials • Sends decision correspondence to appropriate parties, requesting information • Assists with drafting, preparation, and presentation of compliance programs to investigators and their staff • Ensures compliance of regulatory processes with institutional SOPs, FDA, NIH, and other regulations
Requirements
• Bachelor's Degree in relevant field • Not required, but recommended (e.g., SOCRA - CCRP) • 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 a 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
• medical • dental • tuition remission • more
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