Job Description
The Clinical Research Operations Manager plays a pivotal role at the Research Institute, contributing significantly to both industry-sponsored and investigator-initiated clinical trials. This role ensures adherence to trial protocols, FDA regulations, and ICH/GCP guidelines. The Operations Manager supervises workflows, processes, clinical study coordinators, and data support teams involved in patient-facing aspects of clinical research within the department. Additionally, they provide support across various U.S. Division locations as needed. The Operations Manager collaborates closely with business development teams and Study Intake Program Managers to guarantee that all research projects are of high quality, operationally feasible, and aligned with the needs of investigators and patients.
ResponsibilitiesAccountable for meeting accrual metrics and developing strategic measures to improve study and team performance.Interface with Managers and leads for timely initiation and completion of clinical trials.Collaborate with Principal Investigator (PI) to identify and address barriers in clinical studies.Serve as the primary contact for Executive Medical Directors, Institute leaders, and Principal Investigators regarding clinical trials.Develop scalable staffing and operational plans to extend research to various locations within network.Manage duties for effective and compliant clinical research study coordination across multiple therapeutic areas.Ensure the delivery of safe care with respect for all patients/participants.Work with managers and teams to develop study budgets for research projects.Accountable for operational review to ensure appropriate trial selection.Collaborate with leadership to optimize workflow and scheduling for clinical operations.Participate in task forces and meetings related to network clinical trial activities.Work with peer leaders to resource and staff projects within the AHRI portfolio.Provide leadership for additional research functions such as recruitment, data entry, and data management.Guide recruitment strategies and tactics for optimal participant recruitment in Surgical and Orthopedics research.Lead data management teams to ensure standardization and best practices.Develop staffing plans and operational budgets consistent with institution standards.Ensure accurate Medicare Coverage Analysis and compliant billing practices.Create corrective and preventative action plans for safe and compliant care delivery.Perform managerial duties related to the selection, management, and development of research staff.Collaborate with other research departments to ensure regulatory compliance.Establish and maintain SOPs for clinical operations and staff training.Work with Regulatory Manager to meet compliance with regulatory agencies.Serve as a stakeholder for committee and governance meetings.Perform additional duties as directed by Leadership.Monitor and direct daily research operations, reporting issues to the Executive Director of Research Operations.
Essential SkillsClinical researchOperations managementProject managementManagement skillsAdditional Skills & QualificationsBachelor’s degree in medical, scientific, healthcare, business administrative, or related fieldMinimum of five years’ experience Certified Clinical Research Coordinator (CCRC) certification by the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) or Professional Certification in a clinical specialty area in the area of research focusWork Environment
The role will be based onsite at all Orlando locations.
Pay and BenefitsThe pay range for this position is $100000.00 - $130000.00
Benefits from Day One
Paid Days Off from Day One
Career Development
Whole Person Wellbeing Resources
Mental Health Resources and Support
Pet Insurance*
Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)
Workplace Type
This is a fully onsite position in Orlando,FL.
Application Deadline
This position will be accepting applications until Dec 31, 2024.
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