Research Program Manager

Cleveland Clinic•Weston, FL

21h•Hybrid

About The Position

Join the Cleveland Clinic Florida team at the Krupa Center in Weston, where you will work alongside highly skilled and compassionate caregivers and board-certified physicians to provide patient-first healthcare. Cleveland Clinic is consistently recognized as one of the top hospitals in the nation, offering quality preventive care, management of chronic conditions and comprehensive services for the entire family. At Cleveland Clinic, you will receive strong support and recognition, collaborate with dedicated professionals and build a rewarding career with one of the world’s most respected healthcare organizations. As a Research Program Manager, you will lead and oversee a multidisciplinary research team supporting a diverse portfolio of research programs at Weston, with the largest focus on the Heart, Vascular & Thoracic Institute (HVTI). You will supervise research staff, including research nurses and coordinators within HVTI, while also supporting departments with growing research portfolios, such as Infectious Disease, Allergy, and Imaging. This role requires the ability to quickly pivot between disease specialties, as no two days are the same. In this role, you will manage the execution and coordination of multi-center academic clinical trials, oversee both pre- and post-award research activities, and ensure compliance with regulatory agencies, funding requirements, and Cleveland Clinic research administration policies. You will provide operational leadership across multiple research programs, ensuring efficient study execution, regulatory compliance, and high-quality research operations across a broad range of clinical specialties.

Requirements

Bachelor’s Degree in Business Administration, Science or a related field required
Five years of clinical research experience, including project management, financial administration and supervision
Critical thinking skills, decisive judgment and the ability to work with minimal supervision
Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by Responsible Conduct of Research guidelines adopted by the Cleveland Clinic

Nice To Haves

Advanced degree in health care, science or business (may offset some of the experience requirements)
Prior experience in direct supervision of personnel
Prior clinical experience in specialty area
Research experience coordinating regulated research projects
Prior experience with a mixed clinical research portfolio (i.e. corporate sponsored, investigator-initiated, federal grants)
Prior experience with multiple research platforms (i.e. eReg, CTMS, EDCs, Oracle)
Research certification from a recognized clinical research organization may be preferred for specific disease-based areas

Responsibilities

Oversee the organization and execution of research protocols with the proper allocation of resources and adherence to research protocol requirements including; timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
Oversee the research operations for the assigned cluster of departments/centers and/or multi-center academic trial research team including the financial management of research activities in compliance with sponsor regulations and/or contract parameters, development of the annual research budget, maintaining administrative data and reporting on the research activity.
Oversee research personnel, ensuring orientation and training in standard operating procedures (SOPs) in compliance with sponsoring organization, external regulatory agencies and central research administration offices, as well as performance management, career development, corrective action and terminations.
Ensure equitable distribution of workload and allocation of resources.
Oversee the development of training materials and education of research personnel, fellows and staff in study execution and management.
Serve as primary contact for investigators, regardless of funding source, to facilitate research project development, processing and approval routing through the appropriate central research administration offices and systems as defined by institutional guidelines and procedures.
Ensure accurate, complete and timely data entry and review and monitoring of available reports.
Monitor study budgets to ensure compliance with billing guidelines.
Determine and monitor budgets for the appropriate use of human and material resources.
Ensure adherence to the guidelines regarding billing and reimbursement, maintaining familiarity with current and changing reimbursement patterns in order to proactively change processes to ensure revenues.
Develop study budgets, identify patient care charges and assist the Principal Investigator in determining standard of care vs. research charge.
Negotiate industry sponsored research budgets.
Serve as the clinical trial management system liaison for the assigned research operation cluster; ensure the proper use and ensure accurate, complete and timely data entry of study demographics and patient visit calendars for the development of realistic study budgets.
Serve as point of contact for the research billing process for the assigned research operation cluster; monitor and review study budgets to assure adherence to study protocol billing and reimbursement guidelines.
Determine and monitor budgets for the appropriate use of allocated resources, maintaining familiarity with current and changing reimbursement patterns in order to proactively change processes to ensure revenues.
Other duties as assigned.