Senior Manager Clinical Manager Research Institute FT Days
Location Address: 601 E. Rollins St., Orlando, FL 32801
Top Reasons to work at AdventHealth Orlando
Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year
Full Time, Days
You Will Be Responsible For:
Works with Research and Clinical executive team to develop and manage core services and ensure the clinical research operations infrastructure is developed and maintained to support:
The clinical research activities of the AHRI faculty and Staff;
Staff and faculty training, education and development;
Staff recruitment and retention;
Growth of clinical research with a specific focus on increasing accruals in both sponsor- and investigator-initiated clinical trials)
Timeliness of the study startup process to meet or outperform industry standards in site activation;
Quality of Clinical Research, including data integrity, fiscal accountability, monitoring and compliance; and
Portfolio-sustaining partnerships with affiliates and sponsors.
Collaborates with Principle Investigators to ensure research protocols meet SOAR criteria (Scientific, Operational, Administrative Review).
Monitors progress of all research protocols relative to established timelines and key milestones.
Develops core specific budgets with financial assistance
Recruits, trains, provides direct oversite and develops Clinical Operations and core managers to lead current and future operations
Develops and maintains relationships with AdventHealth clinical departments including Clinical Institutes, Office of Research Integrity, Office of Sponsored Projects, and others
Oversees the on-boarding of new clinical staff to the department
What You Will Need:
Bachelor's degree in medical, scientific, business, or related field
Master's degree in clinical or laboratory science, business administration, healthcare, or related field (preferred)
Current, valid State of Florida license as a registered professional nurse, if RN
Certification in research administration, ACRP, SOCRA or other related credentials (preferred)
Eight years' clinical research operations in a healthcare or research setting with demonstrated experience managing teams
Five years' experience as lead of clinical operations, research nurse or research manager with increasing people management responsibilities which includes:
Knowledge of clinical research needs/responsibilities
Program/institute/protocol planning, development and execution
Contract and budget development and negotiation
Proficient with clinical trials management systems (CTMS)
Current knowledge of best practices in the research regulatory environment and clinical research operations, including active participation in national organizations, such as the AACI Research Initiative, SOCRA or ACRP.
Knowledge of best practices in site activation, participant accrual and the collection of high-quality data sets in a clinical research setting clinical research operations and the research regulatory environment
Proficient in negotiating, contract development, and management of contractual obligations
Knowledge of project/process management and ability to define resource needs and direct day-to-day activities.
Clinical research operations management
Research experience which includes regulatory responsibility, grant/sponsor development and acquisition, technical writing, publishing, teaching, speaking, day-to-day research conduct and management, etc.
Demonstrated experience staffing, resourcing and scheduling clinical study coordinator and data teams to meet the needs of a diverse portfolio of research studies
The Senior Manager of Clinical Operations (Sr Manager) is responsible for the development, implementation and coordination of subordinate teams and infrastructure supporting clinical trials spanning multiple therapeutic areas of the AdventHealth Research Institute. Duties and responsibilities include but are not limited to, overall management and financial oversite of the workflows, processes, clinical study coordinators, and data support teams in all patient-facing aspects of clinical research. The Sr Manager will ensure all clinical operations are performed in accordance with Food and Drug Administration (FDA) regulations and the International Conference on Harmonisation/Good Clinical Practices (ICH/GCP) guidelines. The Sr. Manager works closely with business development and Study Intake Program Managers to ensure all research projects are of high quality, are operationally feasible, meet the needs of investigators and patients, and are activated efficiently to meet AHRI study-start metrics. The Sr. Manager works with the AHRI Director of Cores, Core Managers, modality and clinical managers and facilities leads to ensure seamless execution of all clinical trials and research studies. The Sr. 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 direct collaboration with the Office of Sponsored Programs, Office of Research Integrity and the AdventHealth Institutional Review Board (IRB), the Sr. Manager facilitates 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.