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Clinical Trials Assistant

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JOB TITLE:  Clinical Trials Assistant

REPORTS TO: Clinical Research Coordinators and/or Director of Clinical Research Unit (as assigned); Lab Supervisor

JOB LOCATION: Pinnacle Oncology Hematology

JOB SUMMARY:

Processing oncology samples involved in Phase I, II, and III studies. Organizing protocol kits and keeping the inventory up to date and maintained. Provide clinical laboratory staff back up such as being responsible for performing daily functions of the laboratory including, but not limited to processing, analyzing and reporting of specimen results to ensure quality of patient care. Operating clinical laboratory instruments utilized for testing, performing required daily preventive maintenance, and quality control.

RESPONSIBILITIES:

Responsibilities include but are not limited to the following:

1. Responsible for the shipment of Protocol Specific materials and study samples to sponsors, preparation of research materials in accordance with the protocol

2. Act as the liaison for the lab with inquiries/concerns from study laboratories about shipments

3. Processing samples as per protocol

4. Maintain Shipping logs for studies organized and updated

5. Maintain proper protocol kit inventory,

6. Keep all study related records up to date and organized for the laboratory.

7. Provide back up support to the clinical laboratory personnel, i.e. process specimens and properly analyze patient samples and results.

8. Use automated equipment and computerized instruments including but not limited to, CBCs on Abbott Cell-DYN Ruby, Chemistry on Ace Alera, Semi-Automated urines, and several research kits for send out.

9. Prepare reagents; perform quality control, instrument troubleshooting whenever tests systems are not within the laboratory’s established acceptable levels of performance.

10. Performing accurate analysis of laboratory specimens, demonstrating a moderate degree of proficiency and understanding in laboratory procedures and demonstrating competency to facilitate quality patient care and diagnosis.

11. Ensuring compliance with the State of Arizona and Federal licensing/accrediting standards (COLA), including but not limited to safety, infection control, quality management, environmental, confidentiality and patient care.

12. Being able to identify problems that may adversely affect test performance or reporting of test results and either correcting the problem or notifying the Laboratory Supervisor

13. Documenting all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.

14. Other duties as assigned

QUALIFICATIONS:

1. Major in a science related field strongly encouraged

2. Experience with clinical research trials preferred

3. Clinical laboratory experience encouraged.

4. Strong interpersonal and communication skills; excellent organizational skills

5. Must be capable of critical thinking and have the ability to work independently

6. Must be detailed oriented, ability to multi-task, problem solve, and prioritize in busy clinical environment

7. Be able to work flexible shifts.

8. Excellent computer skills i.e. Laboratory Information Systems, Microsoft Office Suite

Non-Exempt Position: salary based on experience