Director Clinical Research Operations Process Compliance

Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With 100+ employed clinicians and more than 700 teammates in 75+ clinic locations and growing. TOI is changing oncology for the better.

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 

 

Experience, Education, and Qualifications 

• 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. Master’s degree preferred 

• 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 

  

Knowledge, Skills and Abilities 

• 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.  

 

The Oncology Institute is based in Cerritos, California. This position may be worked remotely from anywhere in the continental United States, with the understanding that travel may be required.

The estimate displayed represents the typical wage range of candidates hired. Factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role. 

Pay Transparency for salaried teammates$160,000—$190,000 USD