Director, Clinical Research Operations, Process Compliance

Summary

Join The Oncology Institute of Hope and Innovation (TOI) as a Clinical Research Leader! This pivotal role requires an experienced leader to oversee operational teams, ensuring successful study delivery and operational excellence across research programs. You will develop efficient processes, implement quality management systems, and lead strategic improvements aligned with growth targets. Leverage your expertise in clinical trials, technology, and team leadership to integrate best practices. The position offers remote work flexibility within the continental US, with potential travel required. The salary range is $160,000-$190,000 USD.

Requirements

• Bachelor’s degree in biological sciences or related field
• Thorough knowledge of clinical trial processes from pre-award, award, study start-up, patient recruitment, enrollment, study maintenance, and close out
• Excellent verbal and written communication skills
• Organized with attention to detail and proficiency in administrative tasks
• Experience building teams, cross functional organizational structures, and associated processes
• Proficient with Microsoft Office Suite and Clinical Trial Management Systems
• Thorough understanding of ICH/GCP guidelines, regulations, and clinical trial processes
• 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

• Support clinical research infrastructure activities
• Oversee training curriculum for each role in each clinical research department and report training metrics monthly to measure compliance
• Institute risk-based quality management systems 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
• As needed, 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
• As assigned, provide leadership, mentoring and inspiration to cross functional teammates conducting clinical research across all TOI locations in multiple states. Optimize the organizational structure for the clinical research operational team in alignment with streamlined and high-quality clinical trial delivery
• Implement and expand career development plans in alignment with organizational growth
• Supervise managers overseeing the various clinical research functional areas
• Mobilize employees to propel the organization’s vision and mission forward by setting the tone for the entire company and leading by example
• Utilize objectives and milestone goals to track progress and achieve key results
• Maintain consistent open communication with teammates, including priorities, delegation/assignment of action items and regular feedback
• Empower teammates to become innovators, solutions owners and to challenge the status quo for process improvements leading to increased performance and quality
• Coordinate with other TOI departments to manage risks and address complex challenges
• Support TOI Clinical Research Project Manager and other study management support staff in ensuring delivery to the day conduct of clinical trials in accordance with sponsor requirements, ICH/GCP guidelines as well as federal/local laws and regulations
• In coordination with clinical research leadership, support implementation of quality measures and quality control checks to ensure patient safety, data integrity and regulatory compliance
• Support clinical research leadership with strategic planning, core in itiatives, and organization-wide policies and procedures
• Attend any required training, management meetings and/or travel to face-to-face meetings
• Perform other duties assigned by the leadership team

Preferred Qualifications

• Fifteen or more (15+) years of experience in the clinical research industry
• Five or more (5+) years of experience leading cross functional teams
• Experience working with clinical trial management systems, technology, data analytics and process improvement

Benefits

• The position may be worked remotely from anywhere in the continental United States, with the understanding that travel may be required
• $160,000 — $190,000 USD