Position Summary/Essential Duties:

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:

1. Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.

2. 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).

3. Conducts nursing assessments of research participants including appropriate reporting.

4. 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.

5. Establish and maintain communications with Investigator, Sponsor and other internal constituents.