The Research Patient Care Coordinator works under the direction of a licensed health care professional and performs various clinical, research, and administrative tasks for one or more departments. This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. In addition, this position will provide clinical care within the designated scope of practice for research subjects including but not limited to nasal and oral swabs, obtaining vital signs, performing blood draws, performing EKGs and other clinical duties as needed. This position also provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.

1. Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties:
   • A. Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
   • B. Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis.
   • C. Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors.
   • D. With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants.
2. Provides clinical care and support for research subjects.
   • A. Independently performs tasks within their scope of practice after demonstrated competency.
   • B. Assists nurses and providers with clinical care with clinical care as needed.
   • C. Completes all study related training/competencies for clinical components of study protocols
3. Completes all tasks required by study sponsors.
   • A. Provides regulatory documents to sponsor in timely manner
   • B. Completes case report forms, data entry, and maintains source documentation for all study participants
   • C. Tracks and reports adverse events per sponsor and institutional guidelines.
   • D. Coordinates research monitor visits and responds to all data queries.
4. Coordinates studies in compliance with all federal, state, and local regulations/guidelines.
   • A. Completes activities necessary for study start-up including feasibility assessments, confidentiality disclosure agreements and site initiation duties
   • B. Assists with creation of study budgets
   • C. Assists in development of work flow procedures for study team based on specific protocol
   • D. Participates in subject recruitment and enrollment. Coordinates subject informed consent and verifies subject eligibility based on inclusion/exclusion criteria for a given protocol
   • E. Coordinates, schedules, and completes subject visits. This includes physician assessments, medical procedures/tests (laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests), questionnaires, drug dispensation/accountability and all other duties as required by the study protocol(s).
5. In conjunction with the principal investigator, research pharmacist, and other members of the research study team, provides study specific education to the participant and their family. This may include study specific procedures, diary/study log documentation, proper dosage/administration, and disease treatment.
6. Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
7. Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
8. Performs miscellaneous job related duties as requested.

To advance hope, healing and the best healthcare for children and their families

Phoenix Children's will be the leading pediatric health system in the Southwest, nationally recognized for exceptional care, innovative research and advanced medical education.

We realize this vision by:

• Offering the most comprehensive care across ages, communities and specialties
• Investing in innovative research, including emerging treatments, tools and technologies
• Advancing education and training to shape the next generation of clinical leaders
• Advocating for the health and well-being of children and families

• We place children and families at the center of all we do
• We deliver exceptional care, every day and in every way
• We collaborate with colleagues, partners and communities to amplify our impact
• We set the standards of pediatric healthcare today, and innovate for the future
• We are accountable for making the highest quality care accessible and affordable