Regulatory Research Support Specialist
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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.
Responsibilities
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 (WordExcel 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
Qualifications
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 FlorenceeBinders Velos CTMS or other regulatory platforms.
- Understanding ofclinical research protections HIPAA and GCP guidelines.
Senate Bill 1310- The Florida Senate ( 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 bachelors degree;
(c) Six years of direct experience for a masters 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.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Spss
- Data Collection
- Genetics
- R
- Research Experience
- Statistical Software
- Cell Culture
- Molecular Biology
- Microscopy
- Research Laboratory Experience
- Western Blot
About Company
Working at USF With approximately 16,000 employees, the University of South Florida is one of the largest employers in the Tampa Bay area. We are dedicated to cultivating a talented, engaged and driven workforce that strives to be bold. Employees excel in USF‘s rich academic environme ... View more
