Regulatory Compliance Clinical Operations

Dr. Michael McKown

Yukon, OK 580-***-**** ad5nka@r.postjobfree.com LinkedIn Profile

Strategic Clinical Operations Director

Regulatory Compliance Clinical Diagnostics Operations Strategic Planning

Qualified Clinical and Lab Operations Expert with 20+ years of dedicated achievements. Well-known for championing the development of lab and clinical diagnostic operations through effective team building and establishing sample processing functions to scale operations. Uniquely experienced in positioning laboratories as industry competitors within a complex marketplace, reviewing and creating clinical lab reports, and delivering high-impact executive leadership to clinical teams. Drive improvements that generate revenue, cost-savings, and consistent quality improvements during efficient processing of research and clinical samples. Leverage deep understanding of regulatory compliance, securing accreditations from CLIA and CAP to spur lab development.

Core Competencies:

Regulatory Lab Oversight and Compliance • Continuous Improvements • Quality Assurance

Technology Integration • Cross-functional Alignment • Risk Management • Data Analysis

Operational Excellence • Recruiting and Hiring • Resource Optimization • Executive Leadership

PROFESSIONAL EXPERIENCE

Analytical Edge Laboratories - Oklahoma City, OK 2015 - Present

Director of Clinical Operations

Champion growth and development of lab, driving continuous improvements to restructure internal teams, optimize resources, and ensure regulatory compliance with COLA, CAP, CLIA 88, HIPAA, and ISO standards. Exhibit high-impact executive leadership, overseeing all facets of lab operations to maintain utmost quality and patient safety. Leverage unique combination of people development skills, technical acumen, and strategic insight to empower new and existing hires to surpass performance expectations.

Captured efficiency gains by bringing lab into compliance with key industry regulations, including CAP.

Achieved significant decrease in turnaround time and captured efficiency gains through recruitment of high-performing employees.

Navigated budget constraints with ease despite complex economic and market factors, including COVID-19 restrictions, by shifting to PCR testing focus.

Identified process gaps and created scalable solutions to spur lab growth, resulting in $4M in profits in 2023 and boost in overall volume from 20 to 500 samples processed per day.

Elevate Scientific Labs - Oklahoma City, OK 2022 - 2023

Director of Clinical Operations

Capitalized on vast lab achievements and leadership experience, delivering expertise in optimizing patient care and clinical staff support. Forged a collaborative environment throughout tenure, providing a best-in-class patient experience through value-added services for clinical partners and patients. Maintained ISO compliance.

Lowered turnaround time from 10 days to 3 days, outperforming company average.

Cut microbiology lab contamination levels to below 0.1% to guarantee accuracy of results.

Advanced Laboratory Services - Oklahoma City, OK 2012 - 2015

Chief Science Officer

Recruited to direct lab functions, facilitating proficiency testing and procedural alignment through preventative maintenance and in-depth inspections to prevent long-term risk. Guaranteed open communication channels amongst physicians and patients.

Spearheaded launch of 3 urine toxicology labs, preparing individual lab sites with liquid chromatography mass spectrometers (LCMS) and enabling processing of an average of 15K samples monthly with a 72-hour turnaround time.

Served as a key player in designing 3 high-complexity LCMS labs, procuring COLA accreditation.

Fostered the development of new hires through effective coaching and mentorship surrounding LCMS operations and prep methods.

Restructured technology stack to attain 2-fold improvement in sample throughput.

McKown Family Laboratory - Ardmore, OK 2010 - 2012

Laboratory Manager

Complied with industry standards while performing high-complexity testing on clinical specimens, representing a key component in diagnostic functions. Integrated company policies and quality assurance program.

Supported hiring and training of lab staff on multiple testing procedures and equipment such as Cell Dyne, Cobas Chemistry Analyzer, Clinitek Advantus, Coagulation instruments, and VIDAS for hormone testing.

Upheld COLA Accreditation throughout tenure, collaborating with physicians to propel sound decision-making and process improvements.

Murray State College 2004 - 2010

Instructor, Biological Sciences

Delivered expert instruction on Anatomy and Physiology I & II, General Biology, and General Physical Science, securing key inventory and materials to provide effective lab sessions.

Catered to diverse learning styles through various instructional methods, acknowledged for creating a motivated environment for students leading to high student success rates.

ADDITIONAL PROFESSIONAL EXPERIENCE

Attending Physician, Corpus Christi Medical Center, Corpus Christi, TX

Physician, Bayside Family Medicine, Corpus Christi, TX

EDUCATION & PROFESSIONAL DEVELOPMENT

Doctorate of Osteopathy (D.O.), Medicine, A.T. Still University of Health Sciences, Kirksville, MO

Sigma Phi Honor Fraternity, Who's Who Among Colleges Universities

Bachelor of Science in Chemistry & Biology, Southeastern Oklahoma State University, Durant, OK

Blue Key Honor Society Member

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