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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
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)
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.)
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.
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.