Mike Hernandez Email & Phone Number

Aurora, Co, Us

Denver, Colorado, United States

As a Quality Systems Specialist/Sr. Professional, Quality Issue Manager, I am involved in a combination of independent work and collaborative efforts with both internal and external team members to ensure the efficient management and resolution of Quality Issues. Additionally, I provide consultation and guidance on Good Clinical Practice questions, facilitate root cause analyses and actively contribute to the development and implementation of process improvements.Collaboration with key stakeholder subject matter experts within cross-functional study teams is essential to identify and address risks proactively, ensuring their effective mitigation. In addition, I provide specialized expertise in Good Clinical Practice (GCP) and ICH, extending operational support to fortify GCP quality standards across the spectrum of clinical research and development, with a strong emphasis on data quality and management.Quarterly reporting of key Quality Metrics involving the collection, analysis, and presentation of data related to quality issues including the identification of trends, which are further dissected and reported to Senior Leadership and associated stakeholders. Experience with PowerBI to develop quality and valuable metrics and figures with a strong focus on data-driven insights. Duties encompass the maintenance of document and record management systems utilizing Microsoft Excel, which involves organizing, cataloging, and tracking various lists, logs, and records.

Englewood, Colorado

As a Clinical Research Assistant/Project Manager, I assisted with the management of clinical research projects, and managed and supported clinical trial imaging. By implementing new workflows and processes, I was able to streamline clinical trial imaging support and significantly increase efficiency and value.My role encompassed overseeing and assisting in various aspects of clinical research projects. I was responsible for facilitating the successful execution of research studies while adhering to regulatory guidelines and industry best practices. In addition, I analyzed the start-up processes and identified weaknesses by collaborating with the project team to implement more efficient workflows, ultimately improving the overall start-up process while ensuring smooth operations. I streamlined the setup of imaging for research sites requiring various protocol imaging requirements for different modalities such as X-ray, CT, and MRI. I reviewed protocols and imaging manuals to assess feasibility and provide consultation on project implementation at the different outpatient imaging facilities. I managed the setup of imaging projects including reviewing requests for feasibility, development and processing of contracts including budget justifications and fee schedules, development and management of project finances including invoices and financial reports, development of project documents such as order forms or visit worksheets, collaborated with site technologists and implemented appropriate workflows, facilitated training of site staff with sponsors and CROs, and provided overall support where needed. My establishment of the clinical trial imaging support services enhanced efficiency and compliance while providing the company with an additional avenue of revenue with low overhead.

2633 P St. Lincoln, Ne 68503

• Developed, managed, and conducted hour-long activities and lessons on the medical aspects of substance abuse and mental health disabilities for clients struggling with substance abuse and mental health abnormalities.• Audited client files by maintaining accurate records and appropriate files in their medical history records.• Performed clerical duties when necessary such as faxing, copying, developing educational packets and presentations, data entry, answering incoming calls and directing them to appropriate administrators, amongst other clerical duties.• Observed, assessed, and documented the behaviors of clients in order to assist the counselors in the production of a customized treatment plan. • Collaborated with counselors in the production of client treatment plans in order to provide the client with an effective and transitional treatment.• Reinforced positive behaviors by utilizing positive reinforcement/negative punishment to redirect unhealthy behavioral patterns that may interfere with their treatment.• Administered medication to clients during appropriate times. • Monitored the clients' vitals and documented any abnormalities for the nurse to follow up on. • Ensured effective communication by documenting and relaying pertinent clinical directions during shift transitions.

425 Fallbrook Blvd. Lincoln, Ne 68521

• Conducted market research for contracted companies by interviewing eligible participants about the services that were provided.• Interviewed various political, societal, and economical topics as part of the organizations public opinion polls by outbound interviewing a random sample.

Bachelor'S Degree, Major: Biology; Minors: Psychology, Spanish

Activities and Societies: Biology Club, NU Meds, Pre-Health ClubNotable Courses: organic/inorganic chemistry, ecology and evolution.

Education record