Michael Nowicki
Denver,CO
Summary
Clinical Research and Quality Assurance leader with 8+ years of healthcare, oncology research, regulatory compliance, and team management experience. Proven success leading quality assurance programs, audit readiness initiatives, clinical operations oversight, and cross-functional teams across multi-site research organizations. Extensive expertise in GCP compliance, clinical trial oversight, data quality management, protocol adherence, corrective and preventive action planning (CAPA), staff development, and operational excellence. Recognized for building collaborative teams, strengthening compliance programs, and driving continuous process improvement.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Director of Quality Assurance
Western States Cancer Research NCORP
Denver, CO
05.2022 - Current
- Lead Quality Assurance, Data Management, and Drug Accountability teams supporting multi-site oncology clinical research operations.
- Direct staff performance, workload prioritization, training programs, goal setting, and professional development initiatives.
- Oversee internal audits, monitoring visits, cycle reviews, data integrity assessments, protocol compliance reviews, and drug accountability activities.
- Partner with executive leadership to develop and implement corrective and preventive action plans resulting from audits and monitoring findings.
- Support study feasibility assessments and ensure research activities comply with federal regulations, sponsor requirements, and ethical standards.
- Collaborate with Principal Investigators, department directors, clinical research coordinators, and regulatory personnel to maintain operational excellence.
- Develop and maintain SOPs, quality systems, and compliance processes that improve organizational consistency and audit readiness.
- Serve as a member of the leadership team contributing to strategic planning, operational initiatives, and organizational growth.
- Provide protocol guidance and operational support across multiple oncology research studies.
- Maintain oversight of chart reviews, eligibility verification, registrations, treatment compliance, biospecimen collection, and data quality activities.
Clinical Research Coordinator
Centura Health Research Center
Denver, CO
08.2019 - 10.2020
- Coordinated oncology and clinical research studies from patient screening through study completion.
- Ensured protocol compliance, patient safety, regulatory adherence, adverse event reporting, and accurate study documentation.
- Managed subject enrollment, informed consent processes, data collection, specimen tracking, and query resolution.
- Conducted internal audits and supported quality improvement initiatives.
- Collaborated with sponsors, monitors, physicians, and research staff to ensure successful study execution.
- Assisted with budget tracking, Medicare coverage analysis, and clinical trial education initiatives.
- Maintained regulatory files and study documentation in compliance with GCP and FDA requirements.
Donor Tech Lead
Children's Hospital Colorado
Aurora, CO
01.2019 - 08.2019
- Supervised daily donor center operations and provided leadership support for donor services staff.
- Performed whole blood and apheresis collections while ensuring donor safety and product quality.
- Led employee training, competency assessments, process improvement projects, and validation activities.
- Assisted leadership with operational oversight, workflow management, and staff development initiatives.
Research Laboratory Technician
Sarah Cannon Research Institute
Denver, CO
08.2017 - 01.2019
- Supported Phase II and III oncology clinical trials through specimen collection, processing, tracking, and shipment.
- Maintained accurate research documentation, sample inventories, and laboratory records.
- Coordinated sponsor-specific laboratory requirements and responded to research-related data queries.
- Collaborated with research nurses, laboratories, pathology departments, and clinical teams to ensure protocol compliance.
Education
Phlebotomy Certification -
Waubonsee Community College
Sugar Grove, Illinois08.2010
High School Diploma -
Batavia High School
Batavia, Illinois06.2005
Skills
- Clinical Research Operations
- Quality Assurance & Quality Control
- Oncology Clinical Trials
- FDA & GCP Compliance
- Audit & Monitoring Readiness
- CAPA Development & Implementation
- Team Leadership & Staff Development
- Data Quality Management
- SOP Development & Review
- Risk Assessment & Mitigation
- Clinical Trial Training
- Process Improvement
- Lab safety protocols
- Blood collection techniques
- Leadership qualities
- Patient confidentiality
- Sample preparation
- Adaptable mindset
- Appointment scheduling
- Healthcare regulations
- Cross-functional teamwork
- Data entry
- OSHA regulations
- Appointment scheduling
- Healthcare regulations
- Cross-functional teamwork
- Data entry
- OSHA regulations
- Teamwork and collaboration
Certification
Phlebotomy Certification
Languages
English
Native or Bilingual
Timeline
Director of Quality Assurance
Western States Cancer Research NCORP
05.2022 - Current
Clinical Research Coordinator
Centura Health Research Center
08.2019 - 10.2020
Donor Tech Lead
Children's Hospital Colorado
01.2019 - 08.2019
Research Laboratory Technician
Sarah Cannon Research Institute
08.2017 - 01.2019
Phlebotomy Certification -
Waubonsee Community College
High School Diploma -
Batavia High School
PROFESSIONAL HIGHLIGHTS
- 10+ years of healthcare and clinical research experience.
- Leadership responsibility for Quality Assurance, Data Management, and Drug Accountability operations.
- Extensive experience supporting oncology clinical trials and multi-site research programs.
- Strong background in audits, monitoring activities, regulatory compliance, and quality systems management.
- Experienced trainer, mentor, and people leader with a focus on operational excellence and continuous improvement.
- This version is much stronger for:
- Director of Quality Assurance roles
- Clinical Research Manager positions
- Research Operations Manager roles
- Quality Systems Manager positions
- Clinical Trial Management positions
- If you're targeting jobs paying $120k+ in Colorado clinical research leadership, I can also tailor it specifically to ATS keywords used by sponsors, CROs, biotech companies, and pharmaceutical employers.