Clinical Research Regulatory Specialist I

University Hospitals

Clinical Research Regulatory Specialist ensuring safety and compliance in clinical research studies. Managing communications with participants, sponsors, CRO, and regulators for successful trial outcomes.

Posted 5/6/2026full-timeCleveland • Ohio • 🇺🇸 United StatesMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.
Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.
Embraces the principles and practice of leadership and professionalism in clinical research.

Requirements

What you’ll need

Bachelor's Degree and some related experience (Required)
Associate's Degree with 4 years of clinical and/or research experience (Required)
Ability to prioritize the work of multiple projects. (Required proficiency)
Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
Write and edit technical documents. (Required proficiency)
Ability to understand and communicate regulatory requirements to others. (Required proficiency)
Medical terminology. (Required proficiency)
Excellent verbal, written, interpersonal skills. (Required proficiency)

Benefits

Comp & perks

Complies with all policies and standards.
Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial designclinical trial analysisGCP complianceadverse event reportinginvestigational product handlingtechnical writingregulatory requirements understandingmedical terminology

Soft Skills

teamworkleadershipprofessionalismcommunicationdetail-orientedtime managementindependent workprioritization

Certifications

Bachelor's DegreeAssociate's Degree