University Hospitals

Clinical Research Regulatory Specialist II, Peds Hematology/Onc

University Hospitals

full-time

Posted on:

Location Type: Hybrid

Location: Cleveland • Ohio • United States

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Tech Stack

Google Cloud Platform

About the role

  • 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%)
  • Additional Responsibilities Performs other duties as assigned.

Requirements

  • 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
  • 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.
Applicant Tracking System Keywords

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

Hard Skills & Tools
clinical researchregulatory documentationINDIDESOPsGCP guidelinesmedical terminologyproblem solvingnegotiation skillswriting scientific documentation
Soft Skills
leadershipmentorshiptime managementdetail-orientedteamworkcommunicationindependenceeffectivenessinterpersonal skillsverbal communication
Certifications
Society of Clinical Research Associates (SoCRA)ACRP Certified Professional (ACRP-CP)RAPS