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Regulatory Coordinator

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree required; Associates with 4+ years of experience accepted., 2+ years managing regulatory duties for clinical trials., Excellent knowledge of Good Clinical Practice (GCP) and regulations., Strong organizational and project management skills..

Key responsabilities:

Preparations, updates, and reviews of regulatory documents.
Oversees study start-up activities and manages compliance.

Headlands Research Research Scaleup http://www.headlandsresearch.com/

201 - 500 Employees

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Job description

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.