The Regulatory Specialist is for responsible for assisting with the preparation and maintenance of files and binders for regulatory submissions.
• Assists with the process of regulatory document submissions to various boards, committees and industry sponsors.
• Supervises the collection and maintenance of credentialing information, research education records, studies, and safety reports.
• Assists during audits and site visits with monitors concerning regulatory documents.
• Submits or assists in submitting applications for institutional clinical trials.
• Assists in the development of training and education of new staff in regulatory topics.
The Department of Medicine, Division of Infectious Diseases has an exciting opportunity for a Full-Time Regulatory Specialist to work on the UHealth Campus. The Regulatory Specialist assists with the preparation and maintenance of files and binders for regulatory submissions. Additionally, the Regulatory Specialist will prepare protocol submissions for the institutional review board and interact with study sponsors to ensure appropriate regulatory documentation for study activities.
- Facilitates the process of regulatory document submissions to various boards, committees, and industry sponsors.
- Supervises the collection and maintenance of credentialing information, research education records, studies, and safety reports.
- Develops and maintains reporting needs and/or other requirements as established by the IRB, HSRO, and the HIPAA office
- Assists during audits and site visits for matters concerning regulatory documents.
- Submits or assists in the submission of applications for research studies, included those federally industry, and institutionally funded.
- Assists in the development, training, and education of new staff members, and in maintaining communications with study teams.
- Assists in maintaining local data files.
- Maintains current knowledge of applicable regulatory topics.
- Bachelor’s Degree in relevant field
- Minimum 1 year of relevant experience
- Ability to maintain effective interpersonal relationships
- Ability to communicate effectively in both oral and written form
- Skill in collecting, organizing and analyzing data
- Proficiency in computer software (i.e. Microsoft Office, data files)
- Bilingual English/Spanish highly preferred
- Knowledge of processes associated with clinical trials
- Knowledge of applicable federal, state, and local rules and regulations