Clinical Research Regulatory Administrator

Job Description

Job Description

Clinical Research Regulatory Administrator

Overview

Vascular Breakthroughs supports clinical trials for a growing group of vascular surgeons. This role provides administrative and regulatory support to keep study documentation current, ensure staff training compliance, support IRB submissions, and maintain required trial files and systems.

This role is a hybrid, with a combination of in-person and remote work. Periodic travel is required between offices to perform job duties.

Responsibilities

• Keep provider CVs current and compliant for all Principal Investigators and Sub-Investigators
• Ensure signatures are current in RealTime
• Maintain all medical licenses (MLs) in RealTime
• Manage Good Clinical Practice (GCP) and Human Subjects training for all staff
• Manage provider CME tracking and American College of Surgeons credentialing requirements
• Assist with onboarding new staff for clinical research, including:
  • Collect MLs and CVs
  • GCP and HR training
  • Electronic signatures
  • Training for all current studies
• Assist with gathering regulatory documents for new trials and attend training sessions as needed
• Assist providers with ensuring regulatory signatures are current in RealTime (may require travel between offices)
• Document clinical oversight meetings to demonstrate ongoing oversight
• Assist with filing regulatory documents with the IRB, including:
  • Submissions for new studies
  • Annual submissions for current studies
• Maintain Trial Master File (TMF) for investigator-sponsored trials (regulatory requirement)
• Support monitoring activities for investigator-sponsored trials
• Develop and maintain SOPs, including validation updates of RealTime software
• Transcribe data from RealTime to the Electronic Data Capture (EDC) system used by trials

Qualifications/Requirements

• Bachelor's degree (or in-progress degree completion) in life sciences, health sciences, public health, business administration, or a related field preferred
• 0-2 years of relevant experience (internship, co-op, or part-time work) in healthcare administration, clinical research, regulatory coordination, or a related environment preferred
• Strong attention to detail and ability to maintain accurate documentation, version control, and audit-ready files
• Excellent organizational and time-management skills; able to manage multiple tasks and deadlines across studies and sites
• Clear written and verbal communication skills; comfortable following up with providers and staff to obtain required documents and signatures
• Comfort with learning new systems and software platforms (e.g., document management, training tracking, EDC/CTMS tools); proficiency with Microsoft Office
• Ability to work independently while also collaborating with a distributed team across multiple practice locations
• Reliable transportation and willingness to travel between offices as needed (reimbursed)

Compensation

$60,000 - $65,000 per year. Negotiable based on skills and experience.

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