Quality and Risk Lead

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k with employer match

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 to support Valkyrie Clinical Trials Denver site. The role includes leading risk management activities, driving remediation of quality issues, and ensuring inspection readiness across studies.

This position is onsite in Denver, CO and offers a competitive salary and comprehensive benefits. The candidate should have a Bachelor's degree and at least 2 years in clinical research quality, with strong knowledge of GCP guidelines, CAPA, and risk

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 and strong quality and compliance mindset.
• 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.

Responsibilities

• 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.

Skills

Root cause analysis

CAPA processes

Cross-functional leadership

Prioritization

GCP knowledge

Communication skills

Office365

Problem solving

Risk assessment

Influence others

Education

Bachelor's degree

Job description

Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Valkyrie Clinical Trials (VCT)

a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado.

We are actively hiring a Quality Risk Lead to supportour 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)

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 Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees.