Quality and Regulatory Associate

Qualifications

• Bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience
• Previous experience in a clinical research environment or equivalent work environment
• 2-4 years of previous experience as regulatory and/or quality associate in clinical research
• Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred
• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
• Familiarity with clinical trial management system software, preferably Clinical Research IO
• Basic medical knowledge, including medical terminology
• Demonstrated competence in oral and written communication
• Must complete CITI and GCP training certification
• Demonstrated organizational skills and outstanding time management, including keen attention to detail
• Possess impeccable integrity and personal and professional values that are consistent with the company's high standards and mission
• Comply with the company policies, code of ethics, and guiding values at all times

Skills

• Strong analytical and problem-solving skills
• Detail oriented with the ability to perform at a high level of accuracy
• Proactive at identifying and addressing issues in real time
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
• Handle confidential matters and sensitive information with discretion and judgment
• Ability to research regulatory issues and provide recommendations for resolution
• Ability to handle multiple projects simultaneously
• Ability to manage small projects and work independently
• Understand and interpret clinical research protocols and other applicable sponsor documents

Benefits

• 401k
• Medical, dental, vision, long term disability, short term disability, HSA, and life insurance
• 3 weeks of paid time off
• 13 paid company holidays
• Scrub voucher (specific positions apply)