Shakeetha M.

About Shakeetha M.

Ability to multi-task and provide significant attention to detail. Excellent written and oral communication skills along with effective presentation, teaching and coaching capabilities. Proficiency in motivation, critical thinking, problem solving, and organization. Demonstrates the ability to work with confidential information and thrive within a diverse work environment with individuals of all management levels.TA: Oncology/Hematology; Cardiology; Alzheimer\'s Disease; Immunology; GI/GU

Experience

1. Sr Clinical Research Associate i

   PSI CRO

   Jul 2019 — Present

   Acting as the main line of communication between the Sponsor and the site; building and maintenance of good rapport with the site staff involved in the conduct of the study; preparation, conduct, and report of site selection, initiation, routine monitoring, and close-out visits; maintenance of study specific and corporate tracking systems at site and country/regional level;• Ensuring accurate and timely reporting and follow up of AE/SAE and protocol deviations; performance of source data verification and follow up on data queries at site level; • Review of Risk Based Monitoring related information influencing data quality and frequency of site visits; ensuring proper handling, accountability, and reconciliation of all IP and clinical study supplies; review of the status and contents of essential documents and site level; reconciliation of study OSF/TMF at site and country level; • Facilitation and monitoring of the flow of documents/reports and laboratory supplies; support in preparation of draftregulatory and ethics committee submission packages; support in collection of IP-REDS packages at site/country level; facilitation of site budget and contract negotiations; • Management of investigator site payments; project-specific training of investigators; support in preparation of investigator newsletters;

Education

• St. Augustine University

  BS, Biology

  1999 — 2004

• Pfeiffer University

  MHA, Healthcare

  2010 — 2012