Michael J. Wayne Email & Phone Number

Denver, CO, US

Dallas-Fort Worth Metroplex

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to Project Manager (PM), Clinical Lead (CL) and/or Site & Resource Manager (SRM).
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Dallas-Fort Worth Metroplex

Dallas-Fort Worth Metroplex

Dallas/Fort Worth Area

• Conducted pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP.
• Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits.
• Responsible for completion of visit reports and maintenance of study-related databases.

Dallas/Fort Worth Area

• Collected and ensured quality control of clinical research data in support of Phase I oncology research study protocols across multiple disease types.
• Developed procedures to determine subject eligibility; screen, recruit, and enroll subjects while ensuring and documenting proper informed consent.
• Served as a liaison between investigators, medical providers, and study sponsors.
• Functioned as primary contact with CRA, ensuring completeness and accuracy of all study procedures and data upload.
• Updated and informed study sponsor and medical monitor of any SAEs or dose limiting toxicities (DLTs).
• Coordinated regulatory aspects, including safety report preparation, maintaining FDA compliance, and ensuring laboratory standards

Auburn, Alabama Area

• Worked as a Research Assistant evaluating the molecular link between obesity, insulin resistance, various cancers, and fatty liver disease.
• Utilized tissue culture and rodent models, including collection of fat pads, brain, muscle, and hepatic tissue.
• Investigated the causality of insulin resistance in human colon cancer tumor xenografts with the novel insulin resistance inhibitor 2,4-dinitrophenolmethyl ether.
• Implanted subcutaneous tissue-isolated human colon cancer tumor xenografts into animal models.
• Harvested and sectioned subcutaneous tumors for orthotopic implantation.
• Led research investigating the effects of meal timing on the pathogenesis of metabolic syndrome in C57BL/6 mice.

Auburn, Alabama Area

• Worked as a Teaching Assistant for an Honor's College Research Methods course, teaching and supervising undergraduate students in data collection and analysis, as well as demonstrating and overseeing tissue and serum.

Master'S Of Science

Bachelor Of Science - Bs, Biology, Chemistry, Nutrition