Quality and Risk Lead

The posting

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: Serves as the main quality contact and support for site management and study teams, guiding quality and risk oversight within an oncology clinical research setting. This includes, but is not limited to, leading site management and study teams in risk management identification and mitigation activities, conducting risk-based study milestone reviews, assisting study teams with quality issue identification and management, supporting site team with audit preparation and audit activities, and collaborating with site teams and leadership to ensure inspection readiness. Supports Quality Management leadership by providing regular quality oversight communications and contributing to company quality oversight objectives as established within the Quality Management System. Works with the Vice President, Operational Quality, Senior Director, Quality Management, Director of Process Quality, site leads, and other managers to oversee and drive quality within the research site.

ESSENTIAL JOB FUNCTIONS:

• Lead site management and 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-site processes and study progress, changes, and risks. This includes particular attention to oncology-specific risk factors including dose-limiting toxicities, serious adverse event (SAE) rates, complex eligibility criteria, and risks associated with combination therapy or novel oncology agents.

• Track and report metrics for site leadership and provide support for risk mitigation activities.

• Support study teams in identification, investigation, and remediation of quality issues, including root cause, corrective and preventive action, and effectiveness check discussions. This includes issues arising from oncology-specific processes such as SAE/SUSAR reporting timelines, protocol deviations related to dosing modifications, and informed consent complexities unique to oncology patient populations.

• Provide oversight, transparency, and tracking of quality issues for assigned studies and provide metrics to leadership.

• Actively participate in key internal project team meetings and facilitate quality discussions.

• Support site staff and Process Quality in sponsor audits/preparation.

• 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. This includes awareness of heightened regulatory scrutiny applicable to oncology trials, including FDA Oncology Center of Excellence expectations and ICH E6(R3) considerations for high-risk studies.

• 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 the Quality Management team to share lessons learned.

• Additional duties as assigned by management.

Requirements

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is performed in an oncology clinical research site; may include exposure to oncology treatment environments

• Travel may be required up to 10% depending on location

• 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 oncology clinical research quality support. Strong understanding of research activities and processes at research sites, particularly within oncology or hematology/oncology therapeutic areas.

Knowledge and Skills:

· Thorough understanding of quality issue management including root cause analysis and corrective and preventive action processes.

· Thorough understanding of clinical trial processes, including knowledge of oncology-specific processes such as dose escalation/de-escalation designs (e.g., 3+3, BOIN), response assessment criteria (RECIST, iRECIST), and oncology biomarker/companion diagnostic workflows.

· Thorough knowledge of oncology clinical trial site operations, including understanding of common oncology patient safety considerations, investigational oncology product handling requirements, and the heightened ethical and regulatory obligations associated with cancer clinical research.

· General understanding of clinical trial auditing 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, including oncology-specific regulatory guidance including NCI guidelines, FDA oncology drug approval frameworks, CTCAE grading standards, and expedited safety reporting requirements.

· 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.