Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice 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. 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.Qualifications
Associates Degree in Nursing, ADN RN - Registered Nurse Two years of nursing experience in patient care is required.