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: 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 other internal constituents. Provide mentoring and training to junior clinical research staff. DOT/IATA Training (must be obtained within 30 days of hire). Certification in Human Subjects Protection, Good Clinical Practices, HIPAA, and CITI Training (must be obtained within 30 days of hire). CPR/BLS Certification (must be obtained within 30 days of hire). Valid Drivers License/Required Car Insurance Coverage. Research Certification (ACRP or SoCRA). Ability to prioritize the work of multiple projects. Experience in a team setting desirable. Knowledge of GCP and FDA guidelines.
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: 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 other internal constituents. Provide mentoring and training to junior clinical research staff. DOT/IATA Training (must be obtained within 30 days of hire). Certification in Human Subjects Protection, Good Clinical Practices, HIPAA, and CITI Training (must be obtained within 30 days of hire). CPR/BLS Certification (must be obtained within 30 days of hire). Valid Drivers License/Required Car Insurance Coverage. Research Certification (ACRP or SoCRA). Ability to prioritize the work of multiple projects. Experience in a team setting desirable. Knowledge of GCP and FDA guidelines.
Bachelor Degree in Nursing, BSN RN - Registered Nurse BSN or advanced nursing degree (i.e. MSN) required. 2+ years clinical exp in patient care & 5+ yrs clinical research exp (adv degree may offset exp).