Research Regulatory Support Specialist - AdventHealth Orlando FT Days
Location Address:800 N. Magnolia Ave., Orlando, FL 32801
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 Research Regulatory Support Specialist in the Office of Research Integrity (ORI) performs a wide range of duties to support the Centralized Regulatory Team processes and responsibilities, assists with the coordination, implementation, execution, control and completion of specific projects in support of the Regulatory Services core team and ensuring consistency with AHRI Research Services commitments and goals. The Research Regulatory Support Specialist serves as an initial point of contact for the Research Regulatory Team by answering the phones and responding to and managing the general Regulatory inbox. The Research Regulatory Support Specialist provides administrative support to the ORI Director, Regulatory Manager, Regulatory Program Coordinator and Regulatory Staff.
What You Will Need:
EDUCATION AND EXPERIENCE REQUIRED:
Associate degree and three (3) years of administrative support experience in a healthcare setting; OR
Equivalent work consisting of at least three (3) years administrative support experience AND two (2) years of experience in healthcare, clinical research or scientific setting, an institutional review board office, or related field.
EDUCATION AND EXPERIENCE PREFERRED:
Associate degree and Five (5) years of experience in research administrative support.
Experience in areas of regulatory compliance.
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:
Certification through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R).
KNOWLEDGE AND SKILLS REQUIRED:
Strong customer service skills; well organized and communicates well; customer oriented; works independently or in teams, as situation requires.
Ability to maintain strict confidentiality of sensitive information, including employees, other research team members, patients, research subjects, and institution AdventHealth information.
Effective time management skills, capable of handling several tasks/projects at a time and prioritizing responsibilities.
Able to work under deadline pressures.
Proficient in MS Office applications and Adobe.
Team player demonstrating a collaborative and cooperative spirit and a positive attitude.
Ability to work independently with attention to detail.
KNOWLEDGE AND SKILLS PREFERRED:
Current knowledge of clinical research and regulatory requirements.
Knowledge of electronic management systems for research studies, especially IRBNet, Clinical Conductor, and Florence eRegulatory applications.
Assists Research Regulatory Manager, Research Regulatory Program Coordinator, and Centralized Regulatory Team members daily.
Regularly meets with Research Investigators to facilitate signatures on regulatory documents and coordinating investigator utilization of research regulatory portals (e.g., Florence, Shared Investigator Platform, IND safety reports)
Supports Research Regulatory Services across all AdventHealth locations.
Responsible for formatting and maintaining all policies, procedures, and other electronic documents owned by the ORI and assisting with document updates by providing feedback to management.
Maintains and communicates AdventHealth research personnel credentialing process.
Collects and tracks documents to be filed in Central Research Services files in eRegulatory application such as laboratory certificates, CITI certificates of completion, curriculum vitae (CVs), professional licenses, etc.
Provides support to the Regulatory Services team in Florence eRegulatory processes.
Responsible for maintaining and updating the Research Regulatory Services calendar and Research Regulatory Services intranet website.
Assists with ClinicalTrials.gov requirements and manages roles and access to AdventHealth ClinicalTrials.gov account.
Assists with data entry as required for maintaining Research Regulatory metrics and ensures data is captured and completed each month for metrics calculations and reports.
Assist with study close-out activities including preparing research regulatory records to be archived either electronically and/or storage of physical documents off-site
Submit requests for retrieval of physical research records in storage as needed.
General office duties to include: Answering telephone; maintaining Research Regulatory Services email and manager calendars, scheduling meetings.
Willingly adjusts and adapts to changes in workload in a positive manner by altering working hours, and assisting in other areas as approved and observed by supervisor
Manages and/or assists with special Regulatory or ORI projects as assigned.
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