Flourish Research

Quality and Risk Lead

Denver, Colorado, United States

Sponsorship not specified$85k-$95kDetected 3 days ago

GCPProcess ImprovementClinical TrialsClinical ResearchResearchLeadershipCommunicationProblem Solving

About the role

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.
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.

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.
Partner with study teams and site leadership to achieve and maintain a state of 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.
Support study teams in identification, investigation, and remediation of quality issues, including root cause, corrective and preventive action, and effectiveness check discussions.
Support study teams and site leadership with study-specific training requirements and compliance oversight.
Main project quality contact and support for study teams, guiding quality and risk oversight from study award to close.
Lead study teams in risk management assessment, planning, and mitigation.
We are actively hiring a Quality Risk Lead to support our Valkyrie Clinical Trials Denver, Colorado site.

Strong understanding of research activities and processes at research sites.
Provide oversight, transparency, and tracking of quality issues for assigned studies and when required, provide metrics to leadership.
Local travel (up to 60 miles) may be required up to 50% depending on location.

Thorough understanding of root cause analysis and corrective and preventive action processes.
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.
Flourish Research is an equal employment opportunity employer.
Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.

$ 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.

We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.

At Flourish Research, we strive toward excellence.
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.
VCT was founded by leading Clinical Oncologist, Dr.

ecisions 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, phy

This listing is sourced directly from Flourish Research's careers page and normalized into a canonical job model.