Director, Clinical Research Operations, Process Compliance

Summary

Join The Oncology Institute of Hope and Innovation (TOI) as a Clinical Research leader! This role requires 15+ years of clinical research experience and a Bachelor's degree (Master's preferred). You will administer training, implement quality management systems, and lead process improvement initiatives across multiple departments. The position involves overseeing vendor selection for software solutions and managing monthly reporting of key metrics. This remote-friendly position, based in Cerritos, CA, offers a competitive salary range of $160,000-$190,000 USD and may require travel within the continental US. TOI is a growing organization dedicated to advancing oncology care, offering a dynamic and impactful work environment.

Requirements

• 15+ years of clinical research experience at a pharmaceutical company, contract research organization or equivalent clinical research provider
• Bachelor’s Degree or an equivalent combination of education and experience
• Thorough knowledge of clinical trial processes from pre-award, award, study start-up, patient recruitment, enrollment, study maintenance, and close out
• Extensive experience working with clinical trial management systems, technology, data analytics and process improvement
• Lead cross functional teams by motivating and inspiring multiple stakeholders to work together to achieve a common goal
• Clearly communicate with team members, clients and other stakeholders to convey information about processes, changes , purpose and value propositions
• Effectively identify problems, perform root cause analyses, make decisions, and implement the best solution
• Ability to analyze complex datasets and multi-faceted root causes to align with process improvement initiatives and achievement against departmental and corporate goals

Responsibilities

• Administer training curriculum for each role in each clinical research department and report training metrics monthly to measure compliance
• Institute risk-based quality management system for clinical research program, oversee department level quality control checks and holistically analyze results for any risks, alerts or trends as well as to ensure audit readiness
• Establish strategic process improvement initiatives (along with any associated change management plans) based on lessons learned, quality control checks, audit findings, growth targets and innovation goals
• Implement integrated, end-to-end processes across all departments to support training, onboarding, risk management, quality control and process improvements
• Institute structure for quality, operational, productivity and financial metrics and manage monthly reporting
• Oversee vendor selection and implementation of software solutions for various clinical trial activities (Clinical Trial Management System, Screening, Scheduling, eRegulatory, Contracting and Billing, etc) and manage transition from current operations

Preferred Qualifications

Master’s degree

Benefits

• Remote work
• $160,000 — $190,000 USD