Clinical Research Nurse Specialist I, Pulmonary/Critical Care and Sleep Medicine
UH Rainbow Babies & Children's Foundation
Position Summary/Essential Duties:
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:
1. Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
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 source documents and case report forms (CRFs).
3. Conducts nursing assessments of research 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.
5. Establish and maintain communications with Investigator, Sponsor and internal constituents.
Education & Required Credentials, License
Experience & Knowledge:
o Two years of clinical experience in patient care is required; clinical research experience preferred.
o Ability to prioritize the work of multiple projects.
o Experience in a team setting desirable.
o Knowledge of GCP and FDA guidelines.
UH Cleveland Medical Center
UH Cleveland Medical Center is University Hospitals’ flagship academic medical center. With more than 1,000 registered beds, UH Cleveland Medical Center provides primary, specialty and subspecialty medical and surgical care in the heart of Cleveland’s University Circle.