Lead, Clinical Laboratory Scientist - Clinical Research

Prepares specimens for analysis; performs and reports waived, moderate, or high complexity clinical laboratory procedures. Performs all procedures in compliance with written SOPs and FACT, AABB, ACHI, CAP, FDA, and Joint Commission regulations. Assists in teaching students and staff. Demonstrates growth in analysis and troubleshooting of testing systems. Develops regulatory compliance proficiency. Exercises a deep understanding of the operations of the section, and development of staff and future testing. Acts as a technical resource for clinical laboratory staff, Supervisor, Laboratory/Department Director and Medical Director. Works as authorized by the Laboratory Director under Clinical Laboratory Improvement Amendments of 1988, CFR Section 493.1445(a).

Key Responsibilities include:

Maintains knowledge of techniques for preparing and processing biological specimens for clinical analyses using universal precautions. Maintains knowledge and proficiency in manual, semi-automated and automated procedures.
Performs a variety of complex laboratory tests and procedures according to prescribed protocols and assigned schedules. Completes procedures within established turnaround times.
Reviews normal and critical results for accuracy and completeness before they are reported.
Notifies supervisor of unusual results or discrepancies.
Performs quality control procedures including preventive maintenance, calibrations, review of controls, and records data on appropriate forms. Supports and participates in the Quality Assurance efforts and Performance Improvement process.
Utilizes standard laboratory equipment, and records and checks result for completeness and accuracy. Performs data entry of diagnostic information.
Prepares and appropriately labels solutions, reagents, culture media, and stains according to standard formulas and procedures.
Attends staff meetings and required institutional/safety training classes.
Cross-trains (if applicable) through other sections within division/department. Develops and maintains skills to provide coverage as assigned by the supervisor.
Prioritizes work and provides prompt and efficient service. Actively assists coworkers as needed. Maintains orderliness and cleanliness.
Follows safety practices in work areas.
Practices a high level of integrity and honesty in maintaining confidentiality. Maintains a positive customer service image when dealing with division/department staff, patients, physicians, other City of Hope employees and outside vendors.
Recognize, troubleshoot, and resolve problems/adverse situations utilizing analytical thinking skills. Guide and assist others in resolution of complex technical problems, recommending actions and evaluating outcomes.
Participates/maintains compliance with all competency requirements.
Demonstrate, promote, and assist with quality assurance activities to ensure the highest quality outcomes. Completes and documents quality assurance procedures as assigned.
Draft new and revised standard laboratory policies and procedures to meet laboratory and regulatory requirements. Validate new/revised SOPs.
Perform validation protocols for new instrumentation, reagents, and tests. Assist with data analysis and preparation of validation reports.
Reviews new laboratory accreditation program standard requirements for the section on an annual basis. Reviews and assesses policy and procedure changes for compliance with regulatory changes. Works with leadership to create appropriate documentation to meet new and changed requirements.
Assist in preparation for and participate in internal inspections, external proficiency testing (PT) surveys, and properly maintain records to fulfill the requirements of accrediting agencies, including investigating and drafting PT failure responses.
Works with the management team in establishing and monitoring all aspects of an effective quality program, to ensure the validity of all diagnostic laboratory procedures performed in the laboratory section.
Ensure new and revised standard laboratory policies and procedures meet all regulatory requirements and manually audit to monitor that established procedures are being followed.
Design, write and supervise test validation protocols for new instrumentation, reagents, and tests within the section. Also, performs method and equipment comparisons. Analyze data and prepare validation reports.
Evaluate and document staff competency, ensuring all regulatory requirements are met.
Oversee the day to day bench scheduling of staff, workflow processes and workload. Prepare work schedules in coordination with Section Supervisors.
Prepare for and perform external regulatory inspections of other laboratories.
Oversee the collection and analysis of quality performance indicators, identify opportunities for improvement, and perform investigations and root cause analysis related to internal occurrence reporting as directed by leadership.
Performs other related duties as assigned or requested.

Basic education, experience and skills required for consideration:

Bachelor's Degree
Minimum 5 years as a certified or licensed clinical laboratory scientist

Required Certification/Licensure:

Clinical Laboratory Scientist