Regulatory Programs Lead – Clinical Trials (Remote)

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

Benefits offered by this job

Paid Time Off

Health, dental, vision insurance

Flexible Spending Accounts

Adoption assistance

Retirement plan with employer match

Educational assistance

Job summary

Atrium Health Wake Forest Baptist is seeking an experienced Regulatory Services administrator to oversee regulatory activities for NCCT clinical trials. The role ensures compliance with IRB, FDA, HIPAA, and related standards across multiple studies and audits.

The incumbent will supervise regulatory staff, coordinate submissions, and drive CAPA activities, with strong emphasis on policy development and stakeholder collaboration. A master’s degree and management experience are required.

Qualifications

• Masters degree in Health Administration, Nursing, Business, or Basic Science with 3 years of relevant management experience.
• Experience in medical/research environment preferred.

Responsibilities

• Provides regulatory oversight and leadership to staff, including hiring, training, and performance management.
• Oversees regulatory submissions and IRB reviews; ensures compliance with regulations.
• Develops and enforces policies to support compliant and efficient research operations.
• Maintains relationships with stakeholders, sponsors, IRB, and regulatory agencies.
• Monitors regulatory changes and leads implementation of policy updates.

Skills

Communication skills

Scientific knowledge

Travel ability

Regulatory knowledge

Education

Master's degree in Health Administration or related field

Job description

Atrium Health Wake Forest Baptist is seeking an experienced Regulatory Services administrator to oversee regulatory activities for NCCT clinical trials. The role ensures compliance with IRB, FDA, HIPAA, and related standards across multiple studies and audits.

The incumbent will supervise regulatory staff, coordinate submissions, and drive CAPA activities, with strong emphasis on policy development and stakeholder collaboration. A master’s degree and management experience are required.