This position is responsible for completing a variety of clinical and research study activities prior to study implementation through study closure. This position fulfills requests to collect, process, store, and ship/distribute clinical and research biological samples as well as ensures the department fully complies with all federal, state, regulatory agency, and specific institutional requirements. This position receives supervision of completed work activities from the Biorepository Supervisor.

1. Completes all tasks required by clinical departments and research study teams
   • Provides documents to clinical and research teams in a timely manner.
   • Creates and maintains Biorepository research study binders.
   • Works collaboratively with study coordinators and/or principal investigators to assist in sample collection and handling.
   • Processes, stores, and ships samples per study protocol.
   • Monitors and attends site visits.
2. 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:
   • Follows all regulatory requirements, appropriate methods, practices, and procedures for all research activities in designated area.
   • Assists Biorepository Supervisor with the submission of documents to the appropriate IRB and institutional committees as requested.
   • With the Biorepository Supervisor, reviews the study purpose, parameters, and requirements of the studies to determine sample collection, handling, storing, and shipping protocol.
3. Logs samples in an electronic inventory system. Verifies data integrity, accuracy, and organization. Ensures physical samples are stored in the correct positions in the storage equipment
4. Participates in hospital and department operational and quality improvement initiatives; proactively evaluates systems, practices, and assists to create and implement changes to increase and enhance the effectiveness of the operation.
5. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency. Monitors temperature of sample storage areas and equipment. Participates in responding to temperature out-of-range alerts and taking action per policy.
6. Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant laboratory practice and research area.
7. 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