Quality & Risk Lead, Clinical Trials – Onsite Denver

Flourishresearch; Denver (CO); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with 100% employer match on the

First 4% employer match on employee 4%

Tuition reimbursement

Parental leave

Employee referral program

Employee assistance program

Life insurance

Disability insurance

Generous PTO

Job summary

Flourish Research is seeking a Quality Risk Lead for our Denver, Colorado site to guide study teams in risk management and quality oversight from study award through closeout. You will lead risk assessment, issue investigation, CAPA activities, and ensure inspection readiness, providing regular metrics and guidance to leadership and cross‑functional teams.

The role requires a Bachelor's degree and at least two years in clinical research quality support, with strong knowledge of GCP and

Qualifications

• Bachelor’s degree or commensurate experience.
• Minimum 2 years’ experience in clinical research quality support; exceptions may apply to extraordinary candidates with clinical operations background.
• Strong understanding of research activities and processes at research sites.

Responsibilities

• Lead study teams in risk management assessment, planning, and mitigation.
• Identify, investigate, and remediate quality issues including CAPA.
• Provide oversight and metrics tracking for quality issues.
• Participate in internal project meetings and quality discussions.
• Advise study teams and site leadership on quality practices and regulatory requirements.
• Support inspection readiness with leadership.
• Identify opportunities to improve the Quality Management System.
• Share lessons learned within QM team.
• Support study training requirements and compliance oversight.
• Perform other duties as assigned.

Skills

Root Cause Analysis

Cross-functional Leadership

GCP Knowledge

Risk Assessment

Communication Skills

Office 365

Regulatory Knowledge

Prioritization

Education

Bachelor's degree

Job description

Flourish Research is seeking a Quality Risk Lead for our Denver, Colorado site to guide study teams in risk management and quality oversight from study award through closeout. You will lead risk assessment, issue investigation, CAPA activities, and ensure inspection readiness, providing regular metrics and guidance to leadership and cross‑functional teams.

The role requires a Bachelor's degree and at least two years in clinical research quality support, with strong knowledge of GCP and