Lauren Miller
@laurenmiller
Experienced clinical research associate with expertise in trial management.
What I'm looking for
I am a dedicated clinical research professional with substantial experience in clinical operations, adept at managing trial start-up processes and building productive relationships with study sites. My educational background in Clinical Psychology provides me with a comprehensive understanding of scientific and healthcare disciplines, which I have effectively applied throughout my career. I am committed to ensuring site readiness and proactively addressing trial site needs.
In my current role as a Senior In House Clinical Research Associate at MCRA / IQVIA, I serve as the primary liaison for study sites and investigators, overseeing critical start-up activities such as regulatory document management, IRB submissions, and contract negotiations. My experience spans various therapeutic areas, and I have successfully prepared documentation for FDA audits, achieving zero findings. I am continuously eager to expand my skill set and contribute to the success of clinical trials.
Experience
Work history, roles, and key accomplishments
Senior In House Clinical Research Associate
MCRA / IQVIA
Oct 2021 - Present (3 years 8 months)
Served as the primary liaison for study sites and investigators for start-up activities, including gathering regulatory documents, submitting to IRBs, negotiating contracts and budgets, and coordinating shipments of clinical supplies. Conducted both on-site and remote site visits such as qualification, initiation, close-out, and interim monitoring across therapeutic areas. Successfully prepared do
Clinical Trials Coordinator
DermAssociates, PC / US Dermatology Partners
Jan 2016 - Sep 2021 (5 years 8 months)
Negotiated and finalized study budgets including overhead and patient-related costs, facilitating prompt payment processing. Managed study agreements and handled crucial documentation submissions to ensure regulatory compliance and site readiness. Administered various patient procedures essential for trial data collection, such as informed consent and vital statistics monitoring.
Research Coordinator
Henry M. Jackson Foundation for the Advancement of Military
Sep 2014 - Jan 2016 (1 year 4 months)
Ensured compliance with regulatory requirements through collaboration with legal and regulatory teams. Submitted key regulatory documents to IRBs for approval, streamlining study start-up processes. Contributed to executing and reviewing clinical trial agreements, enhancing site legal readiness.
Research Assistant
Westat
Apr 2011 - Sep 2014 (3 years 5 months)
Managed logistics for team meetings and maintained clear communication through minutes and recordings. Oversaw quality control to ensure the accuracy and integrity of trial data submissions. Supported the coordination of funding changes and collaborated with research bodies like CTEP/NIH to align with trial objectives.
Clinical Research Coordinator
Pulmonary and Critical Care Associates of Baltimore, Frankli
Mar 2010 - Apr 2011 (1 year 1 month)
Maintained comprehensive regulatory files and managed data entry into electronic systems to support study accuracy and compliance. Recruited and consented participants for clinical trials, ensuring ethical standards and proper documentation. Coordinated sample and data storage, contributing to effective data management and trial accuracy.
Education
Degrees, certifications, and relevant coursework
Towson University
Master of Arts, Clinical Psychology
Pursued advanced studies in clinical psychology, focusing on theoretical frameworks and practical applications in mental health. Developed expertise in diagnostic assessment and evidence-based therapeutic interventions.
Clemson University
Bachelor of Science, Psychology, Journalism
Grade: Cum Laude
Completed a Bachelor of Science in Psychology, gaining foundational knowledge in human behavior and cognitive processes. Also pursued a minor in Journalism, enhancing communication and research skills. Graduated with Cum Laude honors.
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Location
Authorized to work in
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