Clinical Quality Assurance Specialist

Clinical Quality Assurance Specialist

The Clinical Quality Assurance Specialist supports the maintenance and enhancement of the Quality Management System. This role is vital in maintaining the QA training program, document control, customer complaint program, and CAPA program. The specialist assists in audits of clinical sites and vendors/suppliers, supports the internal audit program, and contributes to the performance metrics system for continual improvement. Additionally, this position manages the review cycle of QA controlled documents to ensure practices align with written procedures, and supports regulatory agency audits.

Responsibilities

• Support the maintenance and enhancement of the Quality Management System.
• Maintain the QA training program, document control, customer complaint program, and CAPA program.
• Assist in audits of clinical sites and vendors/suppliers.
• Support the internal audit program and performance metrics system for continual improvement.
• Manage the review cycle of QA controlled documents to ensure alignment with written procedures.
• Support regulatory agency audits.

Essential Skills

• Knowledge of current GCP regulations.
• Experience working with regulatory agency audits.
• Experience working with Quality Systems for CROs.
• Excellent written and verbal communication skills.
• Proficiency in MS Office.

Additional Skills & Qualifications

• Experience with internal, external, and site audits.
• Familiarity with audit processes and Quality Systems.

Work Environment

This position offers the opportunity to grow within an organization that values internal promotions. The role is primarily remote, with the exception of necessary audit travel. Candidates must reside in Maryland, DC, Virginia, or North Carolina. The position requires up to 25% travel, both domestically and internationally.

Job Type & Location

This is a Contract to Hire position based out of Bethesda, MD.

Pay and Benefits

The pay range for this position is $40.00 - $58.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Aug 26, 2026.