University Hospitals

Clinical Research Specialist II, Peds Hematology/Oncology

University Hospitals

full-time

Posted on:

Origin:  • 🇺🇸 United States • Ohio

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Job Level

JuniorMid-Level

Tech Stack

GoGoogle Cloud Platform

About the role

  • Coordinates implementation of assigned clinical research trials with the Principal Investigator.
  • Submits documents to regulatory review committees and maintains regulatory files.
  • Screens participants for eligibility, obtains informed consent, educates participants, and completes CRFs.
  • Maintains in-depth knowledge of protocol requirements and GCP guidelines.
  • Documents and maintains participant and study records to ensure regulatory compliance.
  • Assists with SOP/grant/protocol development and manuscript/presentation preparation.
  • Establishes and maintains communications with Investigator, Sponsor and internal constituents.
  • Mentors junior clinical research staff.
  • Performs other duties as assigned and ensures PHI compliance.
  • Adheres to policies and procedures and training requirements.

Requirements

  • Education Bachelor's Degree (Required)
  • 2+ years clinical research experience (Required) and Experience in a team setting (Required)
  • Knowledge, Skills, & Abilities: Ability to prioritize the work of multiple projects (Required proficiency)
  • Knowledge of GCP and FDA guidelines (Required proficiency)
  • Knowledge of Electronic Data Capture Programs (Required proficiency)
  • Medical & Research Terminology (Required proficiency)
  • DOT/IATA Training (Preferred proficiency)
  • Ability to train and mentor junior staff (Required proficiency)
  • Detail-oriented person with the ability to collect, compile, and analyze information (Required proficiency)
  • Ability to understand and communicate research protocol requirements to others; able to work independently on multiple tasks and manage time effectively (Required proficiency)
  • Demonstrates customer service excellence with internal and external customers (Required proficiency)
  • Excellent verbal, written, interpersonal and communication skills (Required proficiency)
  • Computer skills (Outlook, Excel, PowerPoint, Word) (Required proficiency)
  • Licenses and Certifications: Certification in Human Subjects Protection (CITI) (Required within 30 Days)
  • Society of Clinical Research Associates (SoCRA) (Preferred) or ACRP Certified Professional (ACRP-CP) (Preferred)
  • Travel: Travel Requirements 10% Travel may be required