Filled-Clinical Research Nurse Specialist I-Center for Clinical Research
- Location: Cleveland, OH
- Posted: Sep 26, 2019
Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice, GCP, guidelines. 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 case report forms, CRF.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.
Education/Expertise: Bachelor’s degree or BSN preferred. Requires 2 years of nursing experience in patient care.
Required Credentials, License and/or Certifications: Registered nurse with valid Ohio license. Within 1 month following 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.
- Ability to prioritize the work of multiple projects.
- Experience in a team setting desirable.
- Knowledge of GCP 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.
- Effective verbal, written and communication skills. Computer skills required: Excel, Access and Word).
-Hours-M-F 8 hrs/day; flexible start time, no nights or weekends, no call
-Preferred experience-research experience.