Posting Note: The manager is looking for the following: • Experience in clinical and epidemiological research. • Experience in IRB preparation, compliance and regulatory aspects of clinical research. • Experience in clinical research project management. • Experience in experimental and other methods such as developing surveys and other instruments used to conduct prospective and retrospective studies for both experimental and non-experimental projects. • Experience in using Red Cap or other similar cloud-based data collection software; • Experience in designing, coordinating, and conducting research activities and statistical studies using statistical software (e.g.,SPSS, SAS, R). • Experience in conducting literature reviews in medicine and public health • Experience in creating and maintaining databases utilizing various computer programming languages or user-oriented software, such as SPSS used to generate information for management decision making and evaluation of programs. • Experience using Microsoft Office (Excel, Access, Word, PowerPoint, Visio). • Coursework in science, statistics, public health, medicine or related field. • Experience in project management and time management. • Experience in working in a diversified team environment and maintaining effective interpersonal relationships

This position provides and coordinates clinical care for research subjects. This position has a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, and accuracy of data collection, data recording and follow-up. This position also engages in study procedures including administration of investigational drugs, detailed clinical assessments including adverse event assessments, and performing laboratory tests. Additional nursing care may be necessitated by the response of the participant to the study intervention. This position is responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory and institutional requirements and reporting. This position will support the Principal Investigator and Research team for departmental studies under minimal supervision.

1. Provides nursing care to research study patients, including:
   • Performing and/or scheduling medical tests including, but not limited to, blood draws, vital sign readings, imaging studies, cardiac and/or pulmonary function tests.
   • Administering study medications and performs patient assessment during clinic visits to determine presence of side effects to medication; notifies principle investigator of findings/issues.
   • Providing patient education and medical information to study patients to ensure understanding of proper medication dosage, administration and disease treatment.
   • Documenting medical data in patient chart to ensure availability of timely records for decision making.
2. Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines, including:
   • Reviewing all regulatory requirements to ensure implementation of appropriate methods, practices, procedures, and protocols for all research activities in noted area.
   • Completing all IRB required paperwork for studies.
   • With the principal investigator, explaining the study purpose, parameters, and requirements of the studies to the participants.
3. Completes all tasks required by study sponsors, including:
   • Providing regulatory documents to sponsor in timely manner.
   • Completing case report forms for all study participants.
   • Tracking and reporting adverse events.
   • Coordinating research monitor visits.
4. Reviews monthly financial reports, including study participant billing, expenditures, and revenue; Prepares budget analysis forms according to study protocol procedures.
5. Participates in recruitment and selection of study participants by interviewing and reviewing medical history to determine compliance with eligibility requirements.
6. Coordinates the process for opening new studies, including:
   • Obtaining needed background material(s) on proposed research projects; presenting findings and information to attending physician/principle investigator.
   • Completing feasibility questionnaires.
   • Circulating the confidentiality disclosure and trial agreements to the appropriate parties.
7. Participates in a variety of professional development programs to ensure ongoing awareness and 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.

Mission

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

Vision

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

Values

• 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