Clinical Research Operations Manager – Surgery & Orthopedics Research - AdventHealth Orlando

All the benefits and perks you need for you and your family:

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)

* Nursing or BU specific benefits and perks

Our promise to you:

Joining AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.

Schedule: Full Time, Days

Shift : Monday – Friday 8am – 5pm

Travel: Travel to Orlando/Altamonte/Celebration/Winter Park.

Location: 601 East Rollins Street Orlando, FL 32803

The community you’ll be caring for: 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

The role you’ll contribute:

The Clinical Research Operations Manager, Surgery and Orthopedics Research (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 Harmonization/Good Clinical Practices (ICH/GCP) guidelines. The Ops Manager oversees the workflows, processes, clinical study coordinators, and data support teams in all patient-facing aspects of clinical research specific to Surgical and Orthopedics Research, and will provide support across multiple U.S. Division locations, where appropriate. The Ops Manager 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 Ops 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 Ops 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. The Ops Manager implements and operationalizes the research strategies of the Digestive Health and Surgery and the Orthopedic Institutes, serving as point of contact for Principal Investigators and Physician Scientists in the various subspecialities within those therapeutic areas, including but not limited to; Interventional Endoscopy, Colorectal Surgery and Surgical Health Outcomes, Inflammatory Bowel Disease and General Surgery,

The value you’ll bring to the team:

Accountable for meeting accrual metrics (actual vs. targeted enrollment) and the development of strategic measures to improve study and team performance

Interfacing with AHRI Core Managers and leads to ensure timely, and efficient initiation and completion of all industry-sponsored and investigator-initiated clinical trials.

Collaborate with Principal Investigator (PI) during Principal Investigator Oversight Meetings to identify barriers and/or support clinical studies, Clinical Research Coordinator/Supervisor in breaking down barriers with respect to operational execution and recruitment challenges.

Serves as escalation and primary point of contact for Executive Medical Directors, Institute leaders, Research Medical Directors and Principal Investigators in the staffing, operations, compliance and performance of the clinical trials and studies within each of the subspecialties.

Develops scalable staffing and operational plans to extend research footprints to clinics, campuses and underserved areas and communities within the AdventHealth network

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.

Manages the delivery of safe care with regard for the dignity and respect for all patients/participants.

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

Accountable for operational review for clinical trial vetting, to ensure appropriate trial selection with respect to resources and patient population.

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

Participates in task forces related to network clinical trial activities in the Rothman Orthopedic network, and Surgery collaborations within the AdventHealth network.

Participates in internal and external meetings, including Rothman Orthopedics, Surgical training symposia and workshops.

Works collaboratively with peer leaders 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, study data entry, research participant scheduling and support, and data management.

For recruitment, guides strategies and tactics that are implemented by AHRI research participant recruitment leaders including; call-center, digital media teams, feasibility or EMR-review teams and functions to ensure optimal research participant recruitment for all studies in the areas of Surgical and Orthopedics research.

For data management, provide leadership of data entry, QA/QC teams to ensure standardization and best practices across all research teams within AHRI.

Responsible for the development of staffing plans and operational budgets in a manner that is consistent with AdventHealth and AHRI standards.

Accountable for accurate Medicare Coverage Analysis and billing grids to ensure compliant billing practices are observed.

Accountable for the creation of corrective and preventative action plans, as necessary, to maintain safe and compliant delivery of care for all research participants.

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.

Establishes and maintain Standard Operating Procedures (SOPs) 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 Manager to implement steps necessary to meet compliance of outside regulatory agencies i.e., Office for Human Research Protection/Food and Drug Administration (OHRP/FDA).

Serves as a stakeholder for committee and/or governance meetings, as appropriate.

Performs other duties and responsibilities as directed by Leadership to ensure efficient operations of AHRI clinical research teams.

Monitors and directs daily research operations and reports any unresolvable discrepancies or problems to the Executive Director of Research Operations.

Orients and oversees performance of department staff on assigned studies.

The expertise and experiences you’ll need to succeed :

Minimum 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 Research 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 leader with increasing people management responsibilities

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

Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) or Professional Certification in a clinical specialty area, in area of research focus

Preferred qualifications:

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

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

Basic Life Support (BLS) Certification

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.

Category: Research

Organization: AdventHealth Orlando

Schedule: Full-time

Shift: 1 - Day

Req ID: 24044020

We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.