Marcellus Johnson
Seattle,WA
Summary
I have developed a robust regulatory compliance and clinical research background. With seven years of experience overseeing compliance and submitting, tracking, and approving applications for multiple clinical trials, I am highly effective at aiding the development of regulatory strategies and submitting applications. I am also successful at working collaboratively with cross-functional internal departments and external contacts.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Regulatory Coordinator II
Fred Hutchinson Cancer Center, FHCC
Seattle , WA
2023.08 - Current
- Collaborated closely with quality assurance personnel to ensure timely resolution of any discrepancies identified during inspections by health authorities.
- Conducted regular audits of internal processes related to safety reporting, labeling, and advertising materials.
- Provided strategic regulatory input to internal and external stakeholders in compliance with FDA regulations.
- Knowledge of Food and Drug Administration, International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to the conduct of human clinical trials
- Reviewed drafted and updated regulatory documents to ensure compliance with local regulations.
Program Coordinator - Urology
Northwestern University
Chicago , IL
2022.04 - 2023.08
- Managed the program's day-to-day operations, ensuring compliance with applicable policies and regulations.
- Reviewed applications and documentation independently or in conjunction with the supervisor to make decisions pertaining to programs.
- Demonstrated knowledge of regulatory guidelines (IRB), knowledge of FDA, GCP, and NIH requirements, and the ability to interpret and synthesize regulations and guidelines
- Maintained FDA compliance and assisted with audits.
- Assisted medical students in research initiatives for high-level publications.
Clinical Coordinator - Urology
Northwestern University
Chicago , IL
2021.09 - 2022.04
- Maintaining, writing, and submitting IRBs and all regulatory documentation for internal and sponsor-related research
- Ensured compliance with all applicable laws, regulations, and procedures governing healthcare service delivery.
- Performed regular audits of medical records for accuracy and completeness.
- Actively oversaw the quality assurance program, leading to improved performance and the maintenance of exceptional care standards.
- Participated in 30+ clinical urology trials.
- Explained policies, procedures, and services to patients.
Clinical Research Coordinator II
University of Chicago Medical Center Hematology-Oncology
Chicago , IL
2019.06 - 2020.04
- Participated in internal audits to assess compliance with applicable laws and regulations.
- Collaborated with interdisciplinary teams to ensure effective delivery of services.
- Maintained detailed records of patient progress and outcomes.
- Improved research-based approaches through participation in research and evidence-based clinical audits.
Clinical Research Coordinator 2
Lurie Children's Hospital of Chicago
Chicago , IL
2019.05 - 2020.02
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Monitored patient safety during clinical trials according to established guidelines.
- Compiled trial-related documents into a master file as required by the sponsor or regulatory agency.
- Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
Laboratory Technician 3 / Clinical Coordinator
Rush University Medical Center
Chicago , IL
2017.10 - 2019.05
- Performed quality control tests on incoming and outgoing materials to ensure safety standards were met.
- Prepared samples for analysis by weighing, filtering, or diluting them as needed.
- Recorded data from experiments into detailed lab reports for supervisors to review.
- Analyzed results of tests using statistical methods to determine the accuracy of results.
- Oversaw QC duties for a Biosafety Level 3 (BSL-3).
Education
BA Chemistry - Chemistry
DePaul University
Chicago, IL01.2017
Skills
- Document Control
- Regulation compliance
- Regulatory Submissions
- Audits
- Policy Implementation
- Staff Training
Personal Information
Title: Program Coordinator - Northwestern University / Northwestern Medicine
Certification
- Human Subject Protection (HSP)
- Good Clinical Practice (GCP)
Timeline
Regulatory Coordinator II
Fred Hutchinson Cancer Center, FHCC
2023.08 - Current
Program Coordinator - Urology
Northwestern University
2022.04 - 2023.08
Clinical Coordinator - Urology
Northwestern University
2021.09 - 2022.04
Clinical Research Coordinator II
University of Chicago Medical Center Hematology-Oncology
2019.06 - 2020.04
Clinical Research Coordinator 2
Lurie Children's Hospital of Chicago
2019.05 - 2020.02
Laboratory Technician 3 / Clinical Coordinator
Rush University Medical Center
2017.10 - 2019.05
BA Chemistry - Chemistry
DePaul University
- Human Subject Protection (HSP)
- Good Clinical Practice (GCP)
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