Clinical Research Nurse Specialist II OB/GYN - Possible Travel

University Hospitals Cleveland, OH

About the Job

Description

Position Summary/Essential Duties:

Works in collaboration with the Principal Investigator to coordinate and implement assigned multiple and/or complex clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and provides mentorship to the junior clinical research staff:

  1. Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files.
  2. 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 case report forms (CRF)
  3. Conducts nursing assessments of clinical trial participants including appropriate reporting.
  4. 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.

Qualifications

Education/Expertise: Minimum Bachelor of Science in Nursing (BSN) from accredited program required.  Requires 2 years of nursing experience in patient care and at least 3 years of clinical research experience. 

 

Required Credentials, License and/or Certifications: Registered nurse with valid Ohio license.  Within 1 month of date-of-hire, completion of:  Certification in Human Subjects Protection/CITI training, Good Clinical Practice and HIPPA; UH Clinical Research Center (UHCRC) Research Orientation; UH Investigator Training.  

 

Experience & Knowledge:

  • Two years of nursing experience in patient care is required. Requires at least 3 years of clinical research experience.
  • Ability to prioritize the work of multiple projects.
  • Knowledge of GCPs and FDA guidelines.

 

 

Special Skills & Equipment Knowledge:

  • Detail-oriented person with the ability to collect, compile, and analyze information.
  • Ability to understand and communicate research protocol requirements to others.
  • Able to work independently on multiple tasks and manage time effectively. Medical terminology. 
  • Excellent verbal, written and communication skills.
  • Computer skills required:  Excel, Access and Word).
  • Travel may be required.