This position is responsible for the coordination of a variety of research projects from pre-study implementation, patient consent, 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. This position fulfils requests to collect, process, store, and ship/distribute clinical and research samples as well as ensures the department fully complies with all federal, state, regulatory agency, and specific institutional requirements.

• Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human
  Research Protections (OHRP), Good Clinical Practices (GCP), Lab safety protocols, and institutional guidelines, which includes the following duties
  
  1. Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area.
  2. Performs data analysis on study inclusion and exclusion criteria to maintain compliance.
  3. Provides consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors.
  4. Assists research team with the submission of documents to the appropriate IRB and institutional committees on an ongoing basis.
  5. With the principal investigator, reviews the study purpose, parameters, and requirements of the studies to determine sample collection, handling, storing, and shipping protocol.
  6. Reviews and follows lab manuals and lab protocols.
• Completes all tasks required by clinical departments and research study teams
  
  1. Provides documents to clinical and research teams in a timely manner.
  2. Creates and maintains research study documents and data.
  3. Creates and submits study budgets for review and approval.
  4. Works collaboratively with study coordinators to assist in sample collection and handling.
  5. Processes, stores, and ships samples per study protocol.
  6. Monitors and attends site visits.
  7. Processes, preps and manages the shipping and receipt of samples per lab protocols.
  8. As needed, maintains and coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.
• 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. As needed, participates in governance committees to ensure research is conducted in ethical manners in alignment with institutional processes and policies.
  
• 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.
  
• 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. Responds to temperature out of range alerts and take actions per policy.
  
• 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.
  
• 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