Clinical Quality Assurance Lead - Hybrid Schedule

Science 37; Morrisville (NC); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Science 37 is seeking a Quality Assurance Specialist to participate in the continuous improvement of our quality system. You will assist with audit plans, remediation of trends, and vendor management, driving quality oversight of clinical trials.

The role reports to the Director, Clinical Quality Assurance and requires strong collaboration across clinical operations, nursing solutions, and medical affairs. First 6 months are in Morrisville, NC, with a later hybrid schedule.

Qualifications

• Bachelor’s Degree in science or related field is required.
• 2+ years of experience in clinical research or other GxP environment.
• Proven cross-functional collaboration experience.
• Knowledge of cGXP regulations and ISO 9001 quality standards.
• Excellent written and oral communication skills.
• Ability to meet deadlines in a fast-paced setting.
• Strong interpersonal and organizational skills.
• Creative problem-solving with sound judgment.
• Experience with electronic quality management systems; familiarity with Compliance Quest is a plus.

Responsibilities

• Lead or participate in client audit preparation, hosting, and follow-up.
• Support continuous improvement opportunities and initiatives.
• Assist with development and refinement of SOPs for clinical and quality operations.
• Assist creation and execution of internal clinical quality audit plans.
• Conduct internal audits of Science 37 cGXP departments.
• Own and execute Vendor Management and Quality programs.
• Stay current on regulations and industry best practices in clinical trials.
• Contribute to Quality Organization improvement projects as needed.

Skills

Cross-functional collaboration

Written & verbal communication

Deadline-driven

Interpersonal skills

Organizational skills

Problem solving

Guidance & structure

Education

Bachelor's degree in science

Tools

Compliance Quest

Electronic QMS

Job description

Science 37 is seeking a Quality Assurance Specialist to participate in the continuous improvement of our quality system. You will assist with audit plans, remediation of trends, and vendor management, driving quality oversight of clinical trials.

The role reports to the Director, Clinical Quality Assurance and requires strong collaboration across clinical operations, nursing solutions, and medical affairs. First 6 months are in Morrisville, NC, with a later hybrid schedule.