At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.

This is a 100% REMOTE position, and is a full-time role.  You can read more about us at headlandsresearch.com. 

Position Overview:

Accelelink is looking for a Regulatory Specialist.  Under the supervision of the Director of Performance Marketing, the Regulatory Specialist will be responsible for ensuring all marketing materials are approved by our Pharmaceutical sponsors and the IRB as well as ensuring we are prepared in advance of trial start dates so we can recruit patients in a timely manner.

Required Education and Experience: 

  • Bachelor’s degree or equivalent
  • Minimum 1 year of experience in regulatory environment required
  • Project Management experience preferred

     

Key Outcomes: 

  • Prepare, review and execute regulatory submissions to the Sponsor/CRO, IRB and other regulatory authorities 
  • Process new submissions throughout the study (Recruitment material, marketing material, etc.) within 24 hours of notification
  • Communicate with PI and Clinical Research Coordinator with regard to pertinent changes to protocol-specific requirements that may apply to the marketing materials
  • Tracks IRB approval of all marketing materials 
  • Communicate directly with sponsors and IRB on advertising fund requests as well as ensure turn around of materials that need approval are done in a timely manner
  • Manage and track all of the study approved material for each sponsor

 

Skills/Competencies: 

  • Extremely detailed oriented
  • Ability to produce high quality work with minimal errors
  • Organized and able to manage high volume of data
  • Display the ability to work with a team and communicate effectively with co-workers and supervisors
  • A team player who can receive and provide constructive feedback
  • Demonstrate professionalism, sense of urgency and self-motivation to achieve required metrics