Remote Regulatory Services Lead for Clinical Trials

Atrium Health Wake Forest Baptist; Charlotte (NC); Remote; USD 61,000 - 91,000; Full time

Job summary

Atrium Health Wake Forest Baptist in Charlotte, NC seeks a Regulatory Services Manager for NCCT clinical research. The role oversees regulatory activities, ensures HIPAA/IRB compliance, and guides staff and processes across many trials.

Requires a Master’s degree with 3+ years of management experience and strong communication and regulatory knowledge. The position offers full-time hours, remote work options, and a competitive pay range.

Qualifications

• Excellent verbal and written communication skills.
• Demonstrates knowledge of scientific and statistical principles.
• Ability to travel to affiliate sites, clinical sites and national meetings.
• Familiar with regulations and guidelines related to clinical research including GCP/ICH/FDA/HIPAA.

Responsibilities

• Provides administrative oversight and leadership to regulatory staff.
• Oversees regulatory submissions, IRB reviews, and study documentation.
• Ensures compliance with regulatory requirements and prepares for audits.
• Leads CAPA development and implementation; monitors timelines and risks.

Skills

Verbal communication

Written communication

Regulatory knowledge

Analytical thinking

Education

Master's degree (Health Administration/Nursing/Business/Science) with 3+ years management

Job description

Atrium Health Wake Forest Baptist in Charlotte, NC seeks a Regulatory Services Manager for NCCT clinical research. The role oversees regulatory activities, ensures HIPAA/IRB compliance, and guides staff and processes across many trials.

Requires a Master’s degree with 3+ years of management experience and strong communication and regulatory knowledge. The position offers full-time hours, remote work options, and a competitive pay range.