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Clinical Trials Applications Specialist II AdventHealth Orlando

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

- Benefits from Day One

- Paid Days Off from Day One

- Student Loan Repayment Program

- Career Development

- Whole Person Wellbeing Resources

- Mental Health Resources and Support

- Pet Insurance*

Our promise to you:

Joining AdventHealth is about being part of something bigger. Its 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

**Shift** : Days

**Location:** 601 EAST ROLLINS STREET, Orlando, 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 Trials Application Specialist II is knowledgeable in the areas of clinical trial budgets and protocols, Medicare coverage analysis, clinical trial financial processes including invoicing and time and effort, patient and study statuses, and reporting in the Clinical Trial Management System (CTMS). The CTMS is provided as a Core One system by AdventHealth IT. The Clinical Trials Applications Specialist II supports CTMS builds and usage for regions participating in research including but not limited to Central Florida, West Florida, Rocky Mountain, Southeast, Southwest and Mid-America. The Clinical Trials Applications Specialist II collaborates with operational research unit stakeholders and other shared research services and administrative departments to ensure CTMS builds support compliant, timely, effective and efficient management of related research activities under the auspices of AdventHealth Research Institute. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

The value you'll bring to the team:

Manages, coordinates, and monitors their assigned projects and tasks in CTMS supporting AdventHealth Research Institutes goals of efficient clinical research study implementation, processes, finances, and reporting, all which support and further improve financial recovery, accurate reporting of enrollment and clinical trial performance, and billing compliance.

Reviews, interprets, and translates study documents such as protocols, informed consents, legal agreements, and budgets to accurately and timely provide builds that support the clinical, financial and compliance operations teams.

Contributes to quality control and assurance functions to ensure that research projects are built and configured within the application efficiently and accurately to support financial recovery and tracking from sponsors and comply with reporting requirements to regulatory, funding, and clinical billing agencies.

Develops and utilizes standard tools, methodologies and templates to aid successful application implementation.

Collaborates with AdventHealth Information Technology to ensure study is available to end-users to ensure timely activation of studies

Advises leadership on CTMS issues that require escalation, and proposes recommendations to research leadership.

Participates in the development, updates, and communication of training materials, policies, and procedures related to CTMS.

Consults with stakeholders and partners to solve simple and complex problems related to CTMS builds applying knowledge of applicable regulations, protocols and budgets, billing compliance and finance requirements, and institutional policies and procedures. Develops and maintains relationships with operational research departments and other internal/external stakeholders/collaborators.

In coordination with management, orients, trains, provides guidance to new operational staff to achieve departmental goals and objectives.

In collaboration with management, follows, develops, and updates established CTMS processes, to ensure metrics and tracking, compliance and document harmonization

Performs other administrative duties such as business requirement gathering, business process redesign, and application support as necessary.

Updates protocol information within application as amendments occur to the protocol schedule of activities or budget.

Interacts with management and staff to provide useful information, guidance, and integrity to CTMS related activities.

Develops service level expectations and assures these expectations are achieved.

The expertise and experiences you'll need to succeed:

+ **Minimum qualifications** :

+ Bachelor's degree in Healthcare, Business Administration, Finance, Computer Science, Information Technology, Nursing or related field

+ Two (2) years of full-time experience in building, amending, and maintaining research studies in CTMS or four (4) years of end-user utilization of the CTMS platform for research related job functions

+ Three (3) years of experience in healthcare, research, research administration, or related field

+ **Preferred qualifications:**

+ Three (3) years full time experience in building, amending, and maintaining research studies in CTMS

+ Three (3) years of experience in clinical research in a related role, such as a clinical research coordinator, monitor, auditor, clinical data analyst, or research budget development

+ Experience developing metrics and reporting in CTMS and utilizing Power BI

+ Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators (SRA), National Council of University Research Administrators (NCURA), Research Administrator's Certification Council (RACC)

+ Registered Nurse

_2/28/22_

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:** 25030456

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.