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training specialist, clinical research coordinator, medl technologist

Humble, TX
October 24, 2018

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Helene F Belton, MPH

Humble, TX *****


Competent health care professional with 15+ years experience in various areas of health-care. Disciplined self-starter with a proven ability to manage multiple assignments efficiently, identify problems and outliers in processes, and develop a plan of action for resolution.

Core Professional Competencies

Extensive knowledge of medical terminology

Creative, energetic presenter

Versed in CLIA, FDA, cGMP, IRB, and OSHA regulations/guidelines

Instructional design and classroom facilitation

Clinical trials management experience

Biologic Specimen Handling and Testing

Prepared biologic specimens for clinical analysis and quality testing.

Prepared reagents and instruments for testing.

Performed a variety of laboratory tests using various testing platforms and evaluated results for acceptability.

Participated in quality control and quality assurance audit activities within the department.

Communicated information on test results and blood product suitability to internal and external customers.

Assisted physicians with conducting clinical exams and collecting biological specimens such as bone marrow aspirations.

Training and Instructional Design

Designed and revised 20+ cGMP-related training courses, including an interactive curriculum on Good Manufacturing Practices which was recognized at Training Magazine’s Online Learning Conference (September 2017).

Facilitated organization-wide training programs for new hires and incumbent staff.

Wrote SOPs for technical and non-technical departmental procedures.

Trained 40+ donor collections staff on operation and maintenance of testing equipment and proper sample handling.

Developed, administered, and evaluated results of staff competency assessments.

Assisted departments in developing training materials to address new or revised processes.

Assisted QA department in conducting internal quality assessment audits to identify compliance deficiencies in assigned departments.

Clinical Research

Demonstrated ability to successfully manage 5 or more clinical trials simultaneously.

Worked with recruitment team to strategize recruitment efforts. Evaluated 50 + recruits for study suitability.

Scheduled subject visits, maintained detailed records of progress/compliance with study protocol.

Assisted physicians with conducting clinical exams and specimen collection.

Followed protocol requirements for shipping study specimens.

Conducted detailed investigation and documentation of adverse events.

Assisted clinical research monitors with site visits.

Attended investigator meetings to gain knowledge of current and future clinical trials.

Management Skills

Directly supervised 7-10 medical technology staff.

Reviewed patient results and monitored data for accuracy and clinical consistency.

Monitored quality control and maintenance records and investigated causes of variances.

Coordinated patient care activities with caregivers to minimize treatment delays and maximize clinical outcomes.

Developed and revised technical procedure SOPs.

Assisted management in interviewing and selecting technical staff.

Reviewed physician notes to clarify questionable orders.

Assisted physicians in selecting diagnostic procedures based on patient clinical picture.

Collected and analyzed data used in performance improvement monitoring activities.

Worked with patient care departments to identify causes of variances and develop/implement plans for process improvement.

Performed/assisted with phlebotomy procedures as needed.

Professional Experience

Gulf Coast Regional Blood Center, Houston, TX

Training Specialist 2008-2018

QC Technician 2006-2008

Clinical Trials Management 2004-2005

Clinical Research Associate

Memorial Medical Center 2000-2003

Technical Support Supervisor

Education & Certifications

Master of Science in Public Health (MPH), Tulane University Medical Center

Nursing Program, Louisiana State Medical Center, (completed two years of program)

Bachelor of Science in Medical Technology (MT[ASCP]), Xavier University of Louisiana

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