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.
Associates Degree in Nursing, ADN 2-5 years nursing experience RN - Registered Nurse BSN pref, CITI Reg, Biomed Research, Human Subjects Protection, Social and Behavioral Research, Good Clinical Practice cert within 3 months of hire.
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.
Location/Region: Cleveland, OH (US - 44101)