Position Overview/Job 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:

• 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 internal constituents.

Position Overview/Job 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:

• 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 internal constituents.

Qualifications:

• Bachelor of Science in Nursing (BSN) from accredited program required and two years of clinical experience in patient care required
• 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 Driver’s License/Required Car & Insurance Coverage.
• Ability to prioritize the work of multiple projects. Experience in a team setting desirable.
• Knowledge of GCP and FDA guidelines.
• Detail-oriented person with the ability to collect, compile, and analyze information.
• Ability to understand and communicate research protocol requirements to others.
• Able to work independently on multiple tasks and manage time effectively.
• Medical terminology. 
• Effective verbal, written and communication skills.
• Computer skills required:  Excel, Access and Word.
• Travel may be required.