Marshay Spencer

About Marshay Spencer

I\'m a skilled Clinical Research Professional with a passion for safeguarding clinical trial data quality, data integrity, and patient safety with hopes of narrowing health disparities in chronic disease as an In-House Clinical Research Associate or in any other Clinical Monitoring role.I have over 10 years of industry experience working in a variety of pharmaceutical clinical trials where I have gained diverse experiences in many therapeutic areas varying phases. I am adept in all aspects of clinical monitoring, especially Site Management, Study Management, Quality Assurance, Patient Safety, Safety Reporting, Data Management, Regulatory Submissions, and Regulatory Guidelines (i.e, ICH-GCP, FDA, IRB, HIPAA, internal SOPs). I have demonstrated success utilizing attention to detail to independently and proactively identify study site vulnerabilities to patient safety and protocol compliance via Source Data Verification (SDV) and Source Data Review (SDR). As a problem-solver, I utilize my strong critical thinking and analytical skills to propose and initiate creative solutions to mitigating risks to Data Quality and Data Integrity.Lastly, I have established proficiency in clinical trial systems such as Electronic Data Capture (EDC), IVRS/IXRS, and Clinical Trial Management System (CTMS). Received high-quality training in electronic Trial Master File (eTMF/TMF) Management. Additional expertise in Subject Recruitment, Direct Patient Care, Phlebotomy, EKG and Medical Terminology.

Experience

1. Director of Operations

   Agile Clinical Research Trials

   Jun 2019 — Present · Atlanta, GA, US

   handling clinical trials from start-up to close-out. completing regulatory documents, EKG\'s, Phlebotomy, urinalysis, UDS, creating source documents, ICF process, entering data into EDC, IP accountability GCP & C-SSRS training.

Education

• Capella University

  Bachelor's degree, Counseling Psychology

• Walden University

  Masters , Clinical Mental Health

• Virginia College

  Associate's degree, Medical/Clinical Assistant

  2010 — 2012