Manages all duties necessary for effective and compliant clinical research study coordination for multiple therapeutic areas, including planning, organizing, and managing all activities related to clinical research operations and execution of timelines
Works collaboratively with peer Clinical Operations Managers to resource and staff all projects within the AHRI portfolio including those that may be outside of primary therapeutic areas they support.
May provide leadership of additional research functions including, but not limited to, research participant recruitment, data entry / data management.
For recruitment, provide leadership of call-center, feasibility or EMR-review teams and functions to ensure optimal research participant recruitment for all research teams within AHRI.
For data management; provide leadership of data entry, QA/QC teams to ensure standardization and best practices across all research teams within AHRI.
Performs a variety of managerial duties that relate to the selection, management, development, and appraisal of research staff in rollup.
Collaborates with other AdventHealth Research departments, including but not limited to the Office of Sponsored Programs, Office of Research Integrity and the Institutional Review Board, to ensure federal, state, local, and institutional regulatory compliance.
Works with regulatory specialists to implement steps necessary to meet compliance of outside regulatory agencies i.e., Office for Human Research Protection/Food and Drug Administration (OHRP/FDA).
What You Will Need:
Bachelor's degree in medical, scientific, healthcare, business administrative or related field
Supervision of Clinical Operations Staff
Minimum of five years? experience as a Research Nurse/Registered Nurse OR non-nurse coordinator in healthcare setting or research site
Minimum of five years? experience in a healthcare or research setting with demonstrated experience managing teams OR
Minimum two years? experience as lead research coordinator OR research manager with increasing people management responsibilities
Knowledge of local, state and federal regulations governing the conduct of clinical research
Specialized knowledge of the unique needs of volunteers participating in clinical trials
Ability to understand situational needs, stakeholder input and drive staffing and resourcing decisions that drive optimal research participant enrollment and trial execution to completion
Proficiency in Microsoft Outlook, Word, Excel, and Access and ability to learn business-relevant software and tools
If nurse, current active State of Florida license as a Registered Nurse
Basic Life Support (BLS) Certification
Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research
Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)
Extensive experience in coordinating industry-sponsored and investigator-initiated clinical trials
Proficiencies in managerial knowledge and skills
The Operations Manager - Clinical Research (Clinical Ops Manager) serves the AdventHealth Research Institute (AHRI) as a key contributor to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and the International Conference on Harmonisation/Good Clinical Practices (ICH/GCP) guidelines. The ClinOps Manager oversees the workflows, processes, clinical study coordinators, and data support teams in all patient-facing aspects of clinical research across a multitude of therapeutic areas. Works closely with business development teams and Study Intake Program Managers to ensure all research projects are of high quality, are operationally feasible and meet the needs of the investigators and patients.
The ClinOps Manager is responsible for meeting accrual metrics (actual vs. targeted enrollment) and execution of timelines and works horizontally with AHRI Core Managers and facilities leads to ensure seamless execution of all clinical trials and research studies. The ClinOps Manager is responsible for the performance of the clinical operations teams they oversee, including the provision of daily management, annual evaluations and mentorship that ensures sustainability of the team. Through collaboration with the Office of Sponsored Programs, Office of Research Integrity and the AdventHealth Institutional Review Board (IRB), the ClinOps Manager ensures smooth and compliant operations for all projects across the therapeutic areas and service lines they serve.
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.
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