Clinical Research Nurse Specialist-GI Clinical Trials Unit

University Hospitals; Cleveland (OH); Sur place; USD 75 000 - 110 000; Plein temps

Résumé du poste

University Hospitals seeks a Clinical Research Nurse Specialist for the GI Clinical Trials Unit to provide age-appropriate nursing care while coordinating protocol-driven studies under GCP guidelines.

The role includes regulatory document submission, participant recruitment and consent, data entry of CRFs, and close collaboration with the Principal Investigator and sponsor to ensure regulatory compliance and study integrity.

Qualifications

• BSN degree in nursing required.
• RN licensed in Ohio or Multi-State Compact required.
• CITI, HIPAA, and GCP training within 30 days.
• BLS certification within 30 days.
• OH Driver's License with car insurance coverage.
• DOT/IATA training within 30 days.

Responsabilités

• Coordinate and implement clinical research studies per GCP guidelines.
• Recruit and screen participants; obtain informed consent.
• Complete CRFs and source documents; ensure regulatory compliance.
• Establish and maintain communications with Investigator, Sponsor, and internal constituents.
• Submit related regulatory documents to committees and maintain regulatory documentation.

Connaissances

GCP knowledge

FDA guidelines

Detail oriented

Time management

Protocol communication

Multitasking

Medical terminology

Verbal communication

Written communication

Excel

Access

Word

Formation

BSN degree

Outils

Excel

Access

Word

Description du poste

Job Description - Clinical Research Nurse Specialist-GI Clinical Trials Unit (260009C4)

Clinical Research Nurse Specialist-GI Clinical Trials Unit - ( 260009C4 )

A Brief Overview

Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements. Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines

What You Will Do

• Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
• Performs day-to-day activities related to clinical research studies including: recruit and screens participants, obtain informed consent, educate participants regarding study requirements, and complete source documents and case report forms (CRFs).
• Conducts nursing assessments of research participants including appropriate reporting.
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.

Additional Responsibilities

• 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.
• 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.

Education

• (BSN) Bachelor's Degree in Nursing (Required)

Work Experience

• 2+ years of clinical experience in patient care (Required)
• Clinical research experience (Preferred)
• Experience in a team setting (Preferred)

Knowledge, Skills, & Abilities

• Ability to prioritize the work of multiple projects. (Required proficiency)
• Knowledge of GCP and FDA guidelines. (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. (Required proficiency)
• Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Medical terminology. (Required proficiency)
• Effective verbal, written and communication skills. (Required proficiency)
• Computer skills : Excel, Access and Word. (Required proficiency)

Licenses and Certifications

• Registered Nurse (RN), Ohio and/or Multi State Compact License (Required Upon Hire) and
• Certification in Human Subjects Protection (CITI) Good Clinical Practices, HIPAA, and CITI Training (Required within 30 Days) and
• Basic Life Support (BLS) (Required within 30 Days) and
• OH Driver's License (Valid) with car insurance coverage. (Required)
• DOT/IATA Training (Required within 30 Days)