Quality and Risk Lead

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

We are actively hiring a Quality Risk Lead to support our Valkyrie Clinical Trials Denver, Colorado site.

Shift: Monday-Friday day shift (40 hours per week)

Location: Onsite, Denver, CO

FLSA Classification: Exempt

Compensation: $85,000 - $95,000 per year (depending on experience)

Purpose

Main project quality contact and support for study teams, guiding quality and risk oversight from study award to close. This includes leading study teams in risk management identification and mitigation activities, conducting risk-based study milestone reviews, assisting study teams with quality issue identification and management, and collaborating with site teams and leadership to ensure inspection readiness. The role supports Quality Management leadership by providing regular quality oversight communications, contributing to company quality oversight objectives as established within the Quality Management System, and working with senior leadership to define and create procedures, train, and implement Flourish Research standards into clinical studies.

Essential Job Functions

• Lead study teams in risk management assessment, planning, and mitigation. Drive risk management activities and tracking, ensuring risk oversight and activities are updated as appropriate based on study progress, changes, and risks.
• Support study teams in identification, investigation, and remediation of quality issues, including root cause, corrective and preventive action, and effectiveness check discussions.
• Provide oversight, transparency, and tracking of quality issues for assigned studies and when required, provide metrics to leadership.
• Actively participate in key internal project team meetings and facilitate quality discussions.
• Provide expert quality advice to study teams and site leadership, responding to consultancy requests for best practices, process optimization, and regulatory requirements.
• Partner with study teams and site leadership to achieve and maintain a state of inspection readiness. Communicate with Quality Management leadership regarding readiness, risks, and gaps.
• Identify areas for continuous improvement of the Quality Management System by sharing feedback on processes and participating in process improvement initiatives as requested.
• Communicate regularly within QM team to share lessons learned.
• Support study teams and site leadership with study-specific training requirements and compliance oversight.
• Additional duties as assigned by management.

Physical Requirements and/or Environmental Factors

• Work is performed remotely from the employee’s home office.
• Local travel (up to 60 miles) may be required up to 50% depending on location.
• National travel up to 20%
• Daily computer use
• Ability to drive and daily availability of an automobile.

Minimum Requirements

Education: Bachelor’s degree or commensurate experience.

Experience: Minimum 2 years’ experience in clinical research quality support; exceptions may apply to extraordinary candidates with clinical operations background and strong quality and compliance mindset. Strong understanding of research activities and processes at research sites.

Knowledge and Skills

• Thorough understanding of root cause analysis and corrective and preventive action processes.
• Collaborative and supportive team player with ability to lead cross-functional initiatives while fostering relationships between quality and operations.
• Ability to prioritize work based on deadlines, priorities, and study team schedules.
• Thorough knowledge of GCP guidelines and research regulations.
• Proactive, flexible, and driven mindset, able to keep yourself and others on task.
• Extremely organized with a high attention to detail.
• Excellent oral and written communication skills.
• Excellent computer skills to include Office365 products.
• Strong problem solving, risk assessment and impact analysis abilities.
• Ability to think independently and influence when appropriate.

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.