Clinical Research Nurse Specialist I - Infectious Disease

Overview

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

What You Will Do

• Submit documents to research review committees and maintain regulatory documentation.
• Recruit and screen participants, obtain informed consent, and educate them regarding study requirements.
• Complete source documents and case report forms (CRFs) while documenting accurate research participant records.
• Conduct nursing assessments and report findings appropriately.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.

Additional Responsibilities

• Perform other duties as assigned.
• Comply with all policies, standards, and the UH Code of Conduct.
• Maintain Protected Health Information (PHI) securely and complete required trainings.

Education & Experience

Must have a BSN in Nursing with 2+ years of clinical patient care. Clinical research experience is preferred. Experience in a team setting is also preferred.

Required Knowledge, Skills, & Abilities

• Ability to prioritize work across multiple projects.
• Strong knowledge of GCP and FDA guidelines.
• Detail-oriented with strong information compilation and analysis skills.
• Effective communication of research protocol requirements.
• Proficient in Excel, Access, and Word.

Licenses and Certifications

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

Physical Demands & Travel

The role involves frequent standing, walking, lifting up to 50 lbs, and other physical tasks. Travel requirements are approximately 10%.

Key skills/competency

• Clinical Research
• Nursing
• GCP
• FDA
• Documentation
• Patient Care
• Regulatory Compliance
• Communication
• Teamwork
• Microsoft Office