Billing, Budget Management, Budgeting, Clinical Monitoring, Clinical Research, Clinical Trial, Clinical Trial Management, Employee Orientation, Federal Laws and Regulations, Financial Management, Forecasting, GCP (Good Clinical Practices), Hospital, ICH Regulations, Intellectual Property (IP), International Health, Leadership, Legal, Maintain Compliance, Neurology, Nonprofit, Nursing, Operations Management, Operations Processes, Operations Research, Organizational Skills, Patient Care, People Management, Performance Analysis, Performance Management, Policy Development, Procedure Development, Project/Program Management, Regulatory Compliance, Resource Management, Staff Training, Standards Development, State Laws and Regulations, Time Management, Willing to Travel
Job Summary and Responsibilities
As our Manager of Research Operations, you will manage and supervise clinical research staff, ensuring the successful and timely completion of clinical trials and full compliance with all relevant regulations.
Every day you will coordinate and monitor all clinical research operational activities, managing trials according to regulations and ICH-GCP guidelines. You will also assist with research approvals, oversee study budgets, manage enrollment/performance, forecast resources, and develop/standardize clinical research policies and procedures.
To be successful in this role, you will demonstrate exceptional leadership in clinical research, expertise in regulatory compliance, and a proven ability to manage complex resources and processes to ensure high-quality, compliant trial execution.
- Participates in the planning, performance and management of all clinical trials in compliance with applicable regulations, ICH-GCP guidelines and internal policies. Acts as an administrative resource helping clinicians and other investigators navigate human subjects research approval processes.
- Coordinates and monitors activities of all clinical research operational staff to ensure successful and timely completion of clinical trials. Works also, and when relevant, with program manager(s), to effectively forecast and manage trials financial performance, including nurse and coordinator assignments.
- Collaborates with legal and IP office as necessary in overseeing and approving study budgets and with staff and billing service units to ensure proper allocation of funds to cover expenses specific to trials activity. Monitors enrollment and study performance based upon contract deliverables and works to effectively forecast resource needs to ensure solid performance.
- Organizes clinical research staff orientation and education offerings and actively participates in learning relating to role. Works to develop standardized working instructions across all programs, and develops all clinical research operations policies and procedures. Develops mechanisms to ensure annual reviews of policies are in place. Monitors research activities to ensure compliance with federal, state and local regulations and guidelines.
Job Requirements
Required
- Bachelors Degree or a combination of education and/or job related experience
- Minimum of eight (8) years of clinical research experience with a minimum of five (5) years of clinical research management
Where You'll Work
Hello Humankindness: Join a Legacy of Healing at Saint Joseph's Hospital and Medical Center (SJHMC)
Ready to make a real difference? Join SJHMC in Phoenix AZ., a 571-bed nonprofit founded by the Sisters of Mercy over 125 years ago. We're more than a hospital; we're a global destination for life-changing care, embracing patients with humankindness.
Here, your calling will flourish. We're not just a workplace; we're a community dedicated to a mission of service.
Leaders in Specialized Care:
- Barrow Neurological Institute (BNI): A world-renowned center for groundbreaking neurological research and innovative treatments.
- Norton Thoracic Institute (NTI): A national leader in advanced thoracic care with pioneering surgical techniques.
- Level I Trauma Center: One of Arizona's busiest ERs, providing immediate, comprehensive care for critically injured patients 24/7.
Why SJHMC?
- Culture of Excellence & Well-being: We care for our people, fostering professional and personal growth.
- Community & Collaboration: Be part of a network committed to global health and well-being.
- Join a Legacy, Shape a Future: Over 20% of our patients travel internationally for our specialized care.
This is an invitation to join a family of dedicated professionals at the forefront of medical innovation, united by the power of humankindness.