Clinical Research Nurse Specialist I, RN - Clinical Trials Unit
Updated: May 08
Cleveland
80
14mi
Job Abstract
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. Essential Functions. Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation. P... more details
Position Summary
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
Essential Functions
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.
Required For All Jobs
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.
Qualifications Education
(BSN) Bachelor's Degree in Nursing . Required
Work Experience
2 years of clinical experience in patient care Required and
clinical research experience Preferred and
Experience in a team setting Preferred
Knowledge, Skills, & Abilities
Ability to prioritize the work of multiple projects. Required
Knowledge of GCP and FDA guidelines. Required
Detail-oriented person with the ability to collect, compile, and analyze information. Required
Ability to understand and communicate research protocol requirements to others. Required
Able to work independently on multiple tasks and manage time effectively. Required
Medical terminology. Required
Effective verbal, written and communication skills. Required
Computer skills : Excel, Access and Word. Required
Travel may be. Required
Licenses and Certifications
Registered Nurse (RN) in the State of Ohio Required and
Certification in Human Subjects Protection (CITI) Good Clinical Practices, HIPAA, and CITI Training Required and
Basic Life Support (BLS) Required and
OH Driver's License (Valid) with car insurance coverage. Required
Additional Licenses and Certifications
DOT/IATA Training Required
in the State of Ohio Required and
Good Clinical Practices, HIPAA, and CITI Training Required and
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