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Primary City/State:

Phoenix, Arizona

Department Name:

Clin Trials Research-Non Fed

Work Shift:

Day

Job Category:

Research

Health care is constantly changing, and at Banner Health, we are at the front of that change. We are leading health care to make the experience the best it can be. We want to change the lives of those in our care – and the people who choose to take on this challenge. If changing health care for the better sounds like something you want to be part of, we want to hear from you.

The **Clinical Research Lab Coordinator** plays a vital role in supporting both clinical and research operations within the memory clinic. This position is responsible for thee facility laboratory, including the collection, processing, and shipment of human biological specimens such as blood, urine, and cerebrospinal fluid (CSF). The coordinator ensures that all lab activities comply with study protocols, federal regulations, Good Clinical Practice (GCP), ALCOA-C principles, and applicable local and state laws.

This role requires strong phlebotomy and laboratory skills, and preferably prior experience in clinical research settings. The coordinator will serve as the primary resource for troubleshooting complex lab procedures and will provide mentorship and training to new team members performing lab functions.

**Schedule** : Monday - Friday, 40hrs wk., between the hours of 8a-5pm

Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Sun Research Health Institute (BSHRI) was founded in 1986. Our team is uniquely, passionately, and strategically committed to ending Alzheimer's disease and other neurodegenerative disorders without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. Banner Research is committed to improving people's lives through comprehensive patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's disease and other neurodegenerative disorders research and care.

POSITION SUMMARY

This position is responsible for managing all aspects related to the facility laboratory, including collecting, processing, and shipping human specimens (blood, urine, and cerebral spinal fluid (CSF)) specimens for patients of the memory clinic and clinical research participants enrolled in a research study. Performs technical and administrative work as required by study protocols, federal regulations, GCP, ALCOA-C, multiple lab vendors, and local and state laws. Provides guidance and mentorship in onboarding new team members interested in performing all procedures within the lab and serves as the main resource to help solve in-depth problems arising from routine and specialized testing procedures.

CORE FUNCTIONS

1. Collects and prepares specimens according to Banner Health policies and procedures, which include but are not limited to, verification of patient/participant identity, correct labeling of all samples and requisitions, collection of blood specimens by skin puncture or venipuncture using appropriate sterile techniques, and maintenance of specimen integrity during the collection process. Collects and prepares all specimens, including blood, cerebral spinal fluid, and urine for numerous study specific lab vendors and local clinical testing. Carefully prepares slides for cell analyses and prepares all blood, CSF, and urine for processing steps.

2. Processes all samples according to both local and central laboratory manuals and study protocols. This includes transferring blood and CSF plasma and serum samples to transfer tubes for local and central safety reporting while additionally managing over 100 transfer aliquots for short- and long-term biomarker storage.

3. Ships samples according to local and central practices per regulatory and IATA guidelines, including batch shipment of back-up samples and longitudinal storage aliquots. Maintains complete inventory of all samples that are collected, shipped, and/or stored onsite per protocol along with maintaining appropriate inventory of dry ice needed for frozen shipments.

4. Manages scheduled visits and walk-ins for clinic and research by setting up supplies needed for daily lab draws and prepares vendor provided phlebotomy lab kits as appropriate. As part of managing schedules and preparations, maintains a complete inventory list of all study specific lab kits across 30-40 clinical research studies while also managing inventory for general medical supplies needed for clinical draws. This also includes managing supply and lab kit expiration and shelf-life stability.

5. Provides technical and procedural training to personnel that work alongside this role in the lab, including supervising venipuncture and specimen processing until competency is achieved. May be responsible for a developing and preparing training materials, competency forms, and presentations for staff education in the clinic and clinical research. Serves as a resource and communication liaison. Participates in department/system-wide committees and multidisciplinary teams.

6. Reviews laboratory records and assures optimal performance of all quality control procedures for laboratory equipment and supplies. Ensures that quality assurance and instrumentation maintenance records meet standards of accrediting and licensing agencies. Assists management in the implementation of QC/QA policies and continuous quality improvement programs. May assist management during routine and for-cause inspections.

7. Tracks supply usage and orders as needed. Supports and identifies waste reduction and expense reduction programs. Assists management in monitoring and controlling expenses throughout the year.

8. Participates in selection, training, and development of staff in the lab. Provides input for functional competency assessments for staff within appropriate timeframes. Coordinates and assists staff with day-to-day activities pertaining to completion of visit requirements across departments (for both clinic and research settings).

9. This role functions independently under minimal supervision. This position has working knowledge of all laboratory functions for patient care and acts as a department resource by participating in providing educational information to internal and external customers. Interacts with physicians, nurses, pharmaceutical sponsors and clients, clinic staff, research staff, principal/sub investigators, and other healthcare professionals in responding to results or quality inquiries and other issues related to test orders and/or testing. Provides access to other system resources when appropriate.

MINIMUM QUALIFICATIONS

Associate's degree or equivalent working knowledge.

Two or more years of experience in the clinical laboratory field, with at least one year in the area of test management/Phlebotomy. One to two years of Clinical research experience preferred as documented by prior experience and completion of required CITI, GCP, and IATA training.

Strong reading, writing, organization and math skills. Must be able to recognize problems, identify the cause and determine solutions. Must have a thorough knowledge of instrumentation and procedures utilized in the section. Must have a working knowledge of regulatory and accreditation requirements.

Advanced computer skills in multiple systems to include Laboratory Information Systems and Hospital Information Systems, as well as ability to use multiple software programs.

PREFERRED QUALIFICATIONS

National phlebotomy certification through an approved certifying body.

Knowledge of medical terminology. Previous training/supervisory experience or training. Work experience and knowledge in appropriate specialty area (e.g., Research, Clinic, etc.).

Additional related education and/or experience preferred.

EEO Statement:

EEO/Disabled/Veterans (https://www.bannerhealth.com/careers/eeo)

Our organization supports a drug-free work environment.

Privacy Policy:

Privacy Policy (https://www.bannerhealth.com/about/legal-notices/privacy)

EOE/Female/Minority/Disability/Veterans

Banner Health supports a drug-free work environment.

Banner Health complies with applicable federal and state laws and does not discriminate based on race, color, national origin, religion, sex, sexual orientation, gender identity or expression, age, or disability