I am looking for a Clinical Research Associate role that offers growth opportunities in clinical research, with a focus on collaboration and regulatory compliance.
Mary McGann
@marymcgann
Detail-oriented Clinical Research professional with regulatory expertise.
What I'm looking for
I am a detail-oriented Clinical Research professional with extensive experience in clinical trial coordination, regulatory support, and data quality oversight. My proven track record includes supporting FDA-regulated trials from start-up to close-out, demonstrating a deep knowledge of GCP, ICH, and FDA regulatory requirements. I excel at managing documentation, participant logistics, and sponsor communications across various therapeutic areas, including ophthalmology, psychiatry, gastroenterology, and infectious diseases.
In my most recent role as a Clinical Research Coordinator at Medix Medical Staffing, I supported the planning and execution of FDA-regulated clinical trials by coordinating with physicians, regulatory staff, and sponsors. I have successfully assisted in trial start-up activities, scheduled monitoring visits, and maintained TMF readiness through continuous quality checks. My experience also includes conducting participant recruitment and managing visits, ensuring compliance with protocols and regulatory standards.
With a strong foundation in data management and analysis, I have provided backend support for clinical trials, including data cleaning and eCRF design. I am currently seeking a Clinical Trial Assistant or Trial Operations Support role in a sponsor or CRO setting, where I can leverage my skills and contribute to impactful clinical research.
Experience
Work history, roles, and key accomplishments
Temp Clinical Research Coordinator II
Medix Medical Staffing
Jan 2025 - Present (5 months)
Support the planning and execution of FDA-regulated clinical trials by coordinating with physicians, regulatory staff, and sponsors. Created and maintained TMF readiness through continuous quality checks, document updates, and version control. Participated in SQV, SIV, IMV, COV.
Conducted participant recruitment, screening, consenting, and enrollment for multi-phase clinical trials. Managed participant visits, medication administration, and follow-ups, ensuring protocol compliance across multiple sites. Participated in SQV, SIV, IMV, and COV.
Clinical Data Analyst
Daniel Furst, MD
Jul 2014 - Mar 2018 (3 years 8 months)
Provided backend support for clinical trials, including data cleaning, eCRF design, and document validation. Developed dashboard visualizations in SPSS and PowerBI to support operational metrics and team reporting.
Education
Degrees, certifications, and relevant coursework
San Diego State University
Master of Public Health, Health Services Administration
1990 - 1995
Grade: 3.67
Activities and societies: Newsletter reporter and editor
Completed a Master of Public Health with a specialization in Health Services Administration. This program provided a comprehensive understanding of healthcare systems and administration.
University of Michigan
B.A. in Psychology, Psychology
Earned a Bachelor of Arts in Psychology with Distinction. The curriculum focused on psychological principles and research methodologies.
Tech stack
Software and tools used professionally
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