Associate Director of Regulatory Affairs - K2 STAFFING LLC

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.

K2 is seeking a talented and experienced Associate Director of Regulatory Affairs to join our Corporate Shared Services team. 

The Associate Director of Regulatory Affairs is responsible for overseeing day-to- day operations of the Regulatory Team across multiple sites. This role serves as a subject matter expert on regulatory processes and best practices, is available as a resource to the K2 team and develops regulatory work flows to support these best practices.

Primary Responsibilities:

• Supervise Regulatory Associates across multiple locations
• Oversee day-to-day regulatory operations across multiple site locations and ensure they are being conducted properly and consistently
• Standardize and define regulatory processes and workflows
• Develop written workflows, job aids, training materials and other materials related to regulatory processes that balance efficiency with FDA requirements
• Communicate with and provide timely updates to study Sponsors, Site Leadership, the Quality Team and CRO representatives/monitors
• Train Regulatory staff (and relevant site staff when applicable) on proper regulatory procedures and processes
• Assist the Quality Team in regulatory preparation for audits and FDA Inspections.
• Train new members of the Regulatory Team and lead their onboarding
• Manage the procurement, implementation, and administration of clinical research E-Reg software. Identify vendors, establish scope of services, present recommended vendors and pricing to Executive Leadership, implement software, data conversion, and ongoing system administration and modifications.
• Provide regulatory support/coverage to the sites as needed.
• Perform spot checks and internal assessments of regulatory files at each site on an ongoing basis Other duties as assigned

Knowledge, Skills, Abilities:

• Excellent customer service skills
• Strong written and oral communication skills
• Ability to multi-task, balance multiple priorities at once and effectively manage time
• Comfort with delegating tasks and training
• Ability to complete routine regulatory tasks in order to support the site (i.e., IRB submissions, new study submissions, filing, DOA management, etc.).
• Takes initiative and follows-up as needed Familiarity with clinical research, regulatory affairs, Good Clinical Practice guidelines, IRB processes, FDA regulations and Sponsor audits/FDA Inspections

Qualifications:

• Minimum of 4 years’ experience in clinical research regulatory affairs
• Minimum of 1 year team leadership or management experience Bachelor’s Degree and/or CCRP preferred

At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:

• Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
• 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
• PTO of 16 days per year, 17 days after the first year of FT employment
• 9 paid Holidays
• K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.