Job Description

Description

Manager Clinical Research Operations – Research Oncology – Orlando

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

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. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

Qualifications

• Bachelor’s degree in medical, scientific, healthcare, business administrative or related field      

• 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

  If nurse, current active State of Florida license as a Registered Nurse

• Basic Life Support (BLS) Certification

• 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

• Ability to lead, accept responsibility, exercise authority, and function independently using effective written and verbal communication in English

• Ability to harmonize interests of investigators, stakeholders and customers within the AHRI to drive research operations

  Supervision of Clinical Operations Staff

• Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research

• Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)

  Master’s degree in medical, scientific, healthcare, business or related field

  Seven years’ experience as a Research Nurse/Registered Nurse OR non-nurse coordinator in healthcare setting or research site

  Demonstrated experience staffing, resourcing and scheduling clinical study coordinator and data teams to meet the needs of a diverse portfolio of research studies

  Extensive experience in coordinating industry-sponsored and investigator-initiated clinical trials

  Proficiencies in managerial knowledge and skills

• Accountable for meeting accrual metrics (actual vs. targeted enrollment) and interfacing with AHRI Core Managers and leads to ensure timely, and efficient initiation and completion of all industry-sponsored and investigator-initiated clinical trials.

• 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 managers in Research Services, Study Intake, Portfolio Management, and clinical study coordinators to develop study-budgets for all research projects within supported therapeutic areas.

• Collaborates with Sr. Clinical Operations Manager and AHRI Core Managers to develop and implement processes that ensure workflow and scheduling are optimized for clinical operations.

• 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.

• Assists in establishing and maintaining Standard Operating Procedures (SOP’s) for Research Institute clinical operations, research training, and certification for staff. Develops approaches to monitor and evaluate the quality of clinical operations at AHRI.

• 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).

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.