Clinical Research Regulatory Specialist II

University Hospitals

Clinical Research Regulatory Specialist managing regulatory operations for clinical studies at University Hospitals Case Medical Center. Coordinating documentation and compliance across multiple studies and phases.

Posted 5/20/2026full-timeCleveland • Ohio • 🇺🇸 United StatesJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center (20%)
Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees (20%)
Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials (30%)
Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations (20%)
Embraces the principles and practice of leadership and professionalism in clinical research. Provides mentorship and training on the clinical trial and regulatory process to staff members (10%)
Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation.

Requirements

What you’ll need

Bachelor's Degree and some related experience (Required) or Associate's Degree with 4 years of clinical and/or research experience (Required)
2+ years of clinical 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)
Ability to work consistently and effectively as part of a high performance work team (Required proficiency)
Ability to understand and communicate regulatory requirements to others (Required proficiency)
Demonstrate problem solving skills and effective negotiation skills (Required proficiency)
Medical terminology (Required proficiency)
Strong written communication skills to write and edit documents with the ability to take scientific documentation and present to the general population (Required proficiency)
Excellent interpersonal and verbal communication skills (Required proficiency)
Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications) (Required proficiency)
Society of Clinical Research Associates (SoCRA) (Required) and ACRP Certified Professional (ACRP-CP) (Required)
RAPS (Required)

Benefits

Comp & perks

Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients
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

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical researchregulatory documentationINDIDESOPsGCP guidelinesmedical terminologyproblem solvingnegotiation skillswriting scientific documentation

Soft Skills

leadershipmentorshipdetail-orientedtime managementteamworkcommunicationindependenceinterpersonal skillsverbal communicationwritten communication

Certifications

Society of Clinical Research Associates (SoCRA)ACRP Certified Professional (ACRP-CP)RAPS