Quality and Risk Lead

Job Description

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. WE SEE YOU. 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 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, but is not limited to, 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. This role will support Quality Management leadership by providing regular quality oversight communications, contributing to company quality oversight objectives as established within the Quality Management System. Work with Vice President, Support Services, Senior Director of Project Quality, Director of Process Quality, site leads and other managers 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.

Requirements

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.

Benefits

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.