Clinical Research Regulatory QA Project Mgmt Coord

Quality Management System Manager

Wage Range : $34.36 - $54.97 per hour

Not a remote position - Kirkland, WA campus

Posted wage ranges represent the entire range from minimum to maximum. For jobs with more than one level, the posted range reflects the minimum of the lowest level and the maximum of the highest level. Some positions also offer additional premiums based on shift, certifications or degrees. Job offers are determined based on a candidate's years of relevant experience, level of education and internal equity.

Job Summary

Responsible for the quality management system for clinical trials. Utilizes a strong understanding of federal, state, and local regulations, such as ICH-GCP and FDA guidelines. Collaborates with clinical teams, sponsors, and ethics committees to identify and correct deviations and ensure compliance from study startup to closeout. Ensures that clinical trial requirements are met and consistent with the needs and vision of EvergreenHealth.

Primary Duties

1. Plans, conducts, and reports internal and external audits of clinical trial processes, sites, and vendors to assess compliance.

2. Assists with regulatory agency audits (e.g., FDA inspections) and sponsor monitoring visits.

3. Develops and implements corrective and preventive action (CAPA) plans for all audit findings and non-compliance issues.

4. Prepares, reviews, and submits regulatory documents to Institutional Review Boards (IRBs), Ethics Committees, and regulatory agencies like the FDA.

5. Maintains and tracks all regulatory documentation, including the eRegulatory system. Ensures all records are accurate and complete.

6. Reviews and approves study-related documents such as protocols, informed consent forms, and other essential documents for regulatory compliance.

7. Develops, implements, and maintains the organization's quality management system (QMS) and Standard Operating Procedures (SOPs) for clinical research.

8. Provides guidance and training to clinical staff on regulatory requirements and quality standards.

9. Contributes to the identification of risks and quality improvement initiatives.

10. Serves as the primary contact for regulatory-related communications with sponsors and monitors.

11. Prepares and presents QA metrics and reports to management, identifying trends and potential process failures.

12. Performs other duties as assigned.

License, Certification, Education or Experience

Required for the position :

Bachelor's Degree in a scientific or health-related field.

3 years of experience in clinical research, quality assurance, or a related regulatory role.

Experience in developing metrics and key performance indicators to track study progress and Sponsor / CRO performance.

Ability to effectively establish priorities and develop objectives, goals and action plans to meet or exceed expectations within a fast-paced matrixed environment.

Proven ability to manage multiple projects, meet tight deadlines, and perform effectively under pressure.

Strong understanding of regulations and GCP requirements for drug development, advanced knowledge of clinical operations and industry standards, and advanced skills partnering with CROs and other third-party vendors.

Proficiency with electronic regulatory systems, electronic data capture (EDC) systems, and Clinical Trial Management Systems (CTMS).

Proven client-facing relevant experience in healthcare, clinical research, project management, or contract research organizations

Desired for the position :

Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA).

Regulatory Affairs Certification (RAC).

Benefit Information : Choices that care for you and your family

At EvergreenHealth, we appreciate our employees' commitment and contribution to our success. We are proud to offer a suite of quality benefits and resources that are comprehensive, flexible, and competitive to help our staff and their loved ones maintain and improve health and financial well-being.

Medical, vision and dental insurance

On-demand virtual health care

Health Savings Account

Flexible Spending Account

Life and disability insurance

Retirement plans 457(b) and 401(a) with employer contribution)

Tuition assistance for undergraduate and graduate degrees

Federal Public Service Loan Forgiveness program

Paid Time Off / Vacation

Extended Illness Bank / Sick Leave

Paid holidays

Voluntary hospital indemnity insurance

Voluntary identity theft protection

Voluntary legal insurance

Pay in lieu of benefits premium program

Free parking

Commuter benefits

Cafeteria & Gift Shop Discount