Sr. Research Support Specialist - Regulatory

This entry-level role ensures adherence to institutional SOPs and applicable regulations while developing foundational expertise in human subject protections and Good Clinical Practice (GCP). 

This position is time limited. This position requires a level II background check.

•    Assist with the preparation and submission of IRB applications, amendments, continuing reviews, and closures. 
•    Upload and organize regulatory documents in Florence eBinders (eISF) following institutional SOPs and version control requirements. 
•    Maintain tracking logs for training, delegation, protocol versions, and other required regulatory documentation. 
•    Enter and update study-related regulatory activity in Velos (CTMS) to support documentation and billing. 
•    Ensure study team credentialing and training documentation are accurate and current. 
•    Assist with audit readiness and inspection preparation by maintaining organized and compliant eBinders. 
•    Support communication with IRBs, sponsors, and internal stakeholders regarding documentation and updates. 
•    Ensure protection of confidential data in accordance with HIPAA and institutional standards. 
•    Participate in team training, internal process reviews, and quality improvement efforts. 
•    Perform other duties as assigned by supervisor or leadership. 
•    Performs other duties as assigned. 

Knowledge, Skills & Abilities 
• Attention to detail and accuracy in documentation 
• Ability to follow regulatory protocols and institutional SOPs Proficiency in Microsoft Office (Word,Excel, Outlook); ability to learn new software systems (e.g., Florence eBinders, Velos CTMS) 
• Skill in organizing and maintaining regulatory files and logs 
• Strong written and verbal communication skills for regulatory correspondence 
• Ability to maintain credentialing and training documentation for research staff 
• Ability to prioritize tasks and meet deadlines in a fast-paced research environment 
• Strong interpersonal skills and ability to work collaboratively with research teams 
• Receptiveness to feedback and willingness to learn and improve 
• Sound judgment and discretion when handling confidential information 
• Ability to communicate clearly with investigators, coordinators, and external partners 
• Dependability and accountability in completing assigned tasks 
• General awareness of research in an academic medical center setting 
• Familiarity with IRB and institutional submission workflows (local and central IRBs) 
• Introductory understanding of clinical trial phases and the role of sponsors, CROs, and regulatory 
agencies 
• Awareness of compliance risks related to protocol deviations and documentation practices 
 

Minimum Qualifications:

This position requires a high school diploma or equivalent and six years of experience in office or administrative support or in research support. College education may be substituted for the required experience on a year for year basis.

Preferred Qualifications:

• Bachelors ’s degree in a scientific, health-related, or business field, OR equivalent combination of education and relevant experience. 
  Experience with Microsoft Office (Word, Excel, Outlook) required. 
• Experience in research administration, IRB submission, or regulatory documentation. 
• Familiarity with Florence eBinders, Velos CTMS, or other regulatory platforms. 
• Understanding of clinical research protections, HIPAA, and GCP guidelines. 

Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is conditional upon meeting all employment eligibility requirements in the U.S.
SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed:
     (a) Two years of direct experience for an associate degree;
     (b) Four years of direct experience for a bachelor’s degree;
     (c) Six years of direct experience for a master’s degree;
     (d) Seven years of direct experience for a professional degree; or
     (e) Nine years of direct experience for a doctoral degree

• Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
• Minimum Qualifications that require a high school diploma are exempt from SB 1310.