Works in collaboration with the Principal Investigator to coordinate and implement assigned multiple and/or complex clinical research studies in accordance with Good Clinical Practice guidelines and provides mentorship to the junior clinical research staff: Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. 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. Conducts nursing assessments of clinical trial participants including appropriate reporting. Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures and internal and external regulatory agencies. Establish and maintain communications with Investigator, Sponsor and internal constituents. Within 1 month of date-of-hire, completion of: Certification in Human Subjects Protection/CITI training, Good Clinical Practice and HIPPA; UH Clinical Research Center Research Orientation; UH Investigator Training.Qualifications
Bachelor Degree in Nursing, BSN RN - Registered Nurse Requires 2 years of nursing experience in patient care and at least 3 years of clinical research experience.