Apply on Employer Site

Akron Children's · 3 hours ago

Regulatory Document Specialist

Akron, OH

Full-time

Hybrid

Entry, Mid Level

1+ years exp

Akron Children's is dedicated to providing regulatory support for clinical research. The Regulatory Document Specialist coordinates with study teams to ensure compliance with all regulatory requirements for clinical research documentation.

Health Care

Responsibilities

Protocol processing

Preparation of informed consent documents to comply with local policies

Preparation for IRB submission

Prepare and submit sponsor's essential regulatory documents

Process IRB submission and approvals

Preparation and maintenance of Regulatory Binders

Strategic review of the regulatory binders prior to monitoring visits

Other duties as required

Qualification

GCPsRegulatory document preparationMS Office proficiencyEffective communication skillsMedical terminologyOrganizational skillsTime management skills

Required

Experience interacting with study monitors and FDA reviewers

Knowledge of GCPs, SOPs, and regulatory documents required for clinical trials

Demonstrates organizational and time management/prioritization skills

Proficiency in MS Office [Outlook, Excel, Word] or similar software is required

Proficiency in the English language with excellent use of grammar and spelling is essential

Demonstrates effective communication skills for relating to and networking with all levels of personnel

Knowledge of medical terminology and diseases

Education: High school diploma and a minimum of four (4) years experience OR Associates Degree and minimum two (2) years experience OR Bachelor's Degree and minimum one (1) year experience working in a direct or related clinical trial setting

Years of relevant experience: One or more

Years of supervisory experience: None