Headlands Research

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Regulatory Coordinator

Job Locations US-Remote
ID
2024-1773
Category
Quality, Training, & Regulatory
Position Type
Regular Full Time

Overview

Are you passionate about clinical research and ready to make a significant impact in the industry? Headlands Research, a leading network of clinical trial sites with 20+ locations across the United States and Canada, is seeking a dedicated Regulatory Coordinator to centralize and streamline regulatory activities across all stages and therapeutic areas of clinical trials.

 

As a Regulatory Coordinator, you will play a pivotal role in driving efficiency at the site level by:

  • Ensuring smooth regulatory processes that enhance study acceptance by sponsors.
  • Empowering Clinical Research Coordinators (CRCs) to focus on participant engagement, thereby improving trial outcomes.
  • Contributing directly to the success and growth of Headlands Research by facilitating faster study start-ups and seamless regulatory maintenance.

 

To excel in this role, you’ll need:

  • A strong mastery of clinical trial regulatory management, including start-ups and ongoing maintenance.
  • Exceptional organizational and project management skills to manage multiple sites and studies simultaneously.
  • Outstanding interpersonal communication skills to foster efficient collaboration across internal teams and with external partners, such as sponsors, CROs, and IRBs.

 

Why Join Us?

  • Meaningful Impact: Your work will directly contribute to advancing medical research and improving lives.
  • Career Development: Join a growing network that values innovation and offers opportunities for professional growth.
  • Collaborative Culture: Be part of a supportive team that thrives on collaboration and shared success.

 

 

Responsibilities

  • Prepares, updates, and reviews regulatory and study documents for compliance.
  • Prepares and reviews regulatory documents for submission to sponsors.
  • Reviews and confirms receipt of monitoring visit follow-up letters from study monitors.
  • Maintains electronic Investigator Site File of all regulatory documents
  • Collaborates with study team members to prepare IRB submission materials throughout each study’s lifecycle.
  • Maintains IRB approval of open studies by completing continuing reviews.
  • Oversees study start-up activities; assesses risk for delay in start-up and proactively collaborates with stakeholders to resolve risk.
  • Serves as a liaison between internal (Investigators, Site Directors) and external (sponsors, CRO, IRB) stakeholders.
  • Maintains knowledge of federal and local regulations & guidance, and company guidelines regarding clinical trials.
  • Provides guidance to study team members to ensure compliance with rules and regulations associated with clinical research studies.

Qualifications

  • Bachelor’s degree required; will also accept Associates degree with 4+ years of equivalent experience
  • 2+ years of experience directly managing and responsible for regulatory duties for clinical trial studies required
  • Certification by a professional clinical research organization highly preferred
  • Excellent knowledge of Good Clinical Practice (GCP) and all current federal and local regulations required
  • Demonstrates skills highly adaptable from another cGXP work environment.
  • Extreme attention to detail
  • Ability to easily and quickly develop rapport with external and internal customers and team members.
  • Enhanced ability to lead without authority and communicate effectively with a diverse team of individuals throughout all levels of an organization.
  • Strong organizational and project management skills are a must.
  • Comfortable taking direction from supervisor and working autonomously.
  • Technology skills required, including Microsoft Office suite.

 

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