Zoning Research Analyst
Blew & Associates, P.A.
Clinical Research Specialist II, Peds Hematology/Oncology
University Hospitals
full-time
Posted on:
Location: Ohio • 🇺🇸 United States
Visit company websiteJob 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
