Clinical Trials Applications Specialist – Research Administration - Orlando

Location Address:  800 N. Magnolia Ave., Orlando, FL 32802

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

Work Hours/Shift:

•  Full Time, Days

You Will Be Responsible For:  

The Clinical Trials Applications Specialist is responsible for management, implementation, execution, and completion of projects ensuring consistency and compliance with established guidelines and goals. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

What You Will Need:

EDUCATION AND EXPERIENCE REQUIRED:

• Associate’s degree in Healthcare, Business Administration, Finance, Computer Science, Engineering, Information Technology, Nursing or Research-related field
• Three years of experience in related clinical research, research administration, or programming

EDUCATION AND EXPERIENCE PREFERRED:

• • Bachelor’s degree in Business Administration, Finance, Healthcare, or Research-related field
  • Experience working with CTMS in support of clinical research
  • Experience as a clinical data analyst or programmer

LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:

• Certification by a professional research organization such as Society of Clinical Research 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

KNOWLEDGE AND SKILLS REQUIRED:

• Proficient Microsoft Office Suite skills (Word, Excel, and Outlook)
• Ability to be a self-starter and detail oriented
• Strong interpersonal and oral and written communication skills
• Strong organizational and analytical skills
• Knowledge of customer service and appropriate methods of communication
• Ability to meet fixed deadlines, multi-task a high volume of complex workload requirements and interact with a variety of professions in multiple hospital departments
• Knowledge of hospital policies and procedures regarding clinical research
• Knowledge of research, IT, or database operations

KNOWLEDGE AND SKILLS PREFERRED:

• • Knowledge of International Conference on Harmonization (ICH) Good Clinical Practice guidelines, healthcare compliance and federal regulations related to clinical research
  • Knowledge of study phases in relation to clinical development
  • Knowledge of CTMS and/or relevant software applications
  • Advanced knowledge in Excel (V-Lookups, Pivot Tables, Index, etc.)

Job Summary:

• Manages, coordinates, and monitors specific projects and tasks to build an effective CTMS infrastructure that supports AdventHealth Research Institute’s goals of efficient clinical research study implementation, processes, finances, and reporting, all which further improve the experiences of participants on clinical trials. 
• Performs quality control and assurance functions to ensure that research projects are built and configured within the application efficiently and accurately to support reporting requirements to regulatory, funding, and clinical billing agencies.
• Reviews, interprets, and translates study documents such as protocols, informed consents, legal agreements, and budgets for the implementation of clinical trials operations within the application timely.
• Develops and utilizes standard tools, methodologies and templates to aid successful application implementation.
• Optimizes CTMS application efficiency by working collaboratively with institutional partners to integrate with other clinical operating system such as the electronic medical record system.
• Collaborates with institutional partners to define CTMS issues that require escalation, and propose and present recommendations to research leadership.
• Contributes to the development and maintenance of training materials, policies, and procedures related to CTMS.
• 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 calendar or budget.
• Develops service level expectations and assures these expectations are achieved.