Focused Clinical Trial Lead/Manager well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 4 years of related experience to a challenging new role. Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Drive all clinical aspects from planning, execution, control, and closures.
Ensure vendors are set up and trained in accordance with clinical trial requirements.
Review the regulatory binder for accuracy and completeness.
Facilitate clinical trial team meetings and trainings needed.
Examine data queries and protocol deviations to determine educational opportunities for cross-functional team and broader organization.
Collaborate in the preparation and conduct of Medical Quality Assurance (MQA) audits and FDA inspections.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Followed informed consent processes and maintained records.
Maintained compliance with protocols covering patient care and clinical trial operations.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
Clinical Enrollment Specialist, 08/2020 - 05/2021 University Of Wisconsin Madison – Madison, WI,
Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
Collected data and followed research protocols, operations manuals and case report form requirements.
Coordinated clinical trials focused on disorders such as HER-2 and Prostate Cancer.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collected, evaluated and modeled collected data.
Followed informed consent processes and maintained records.
Maintained compliance with protocols covering patient care and clinical trial operations.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Resolved conflicts and negotiated mutually beneficial agreements between parties.
Eliminated downtime and maximized revenue by providing top project quality control.
Completed all paperwork, recognizing any discrepancies and addressing them in a timely fashion.
Worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
Collaborated with On Study team and Principal Investigators to safely and thoroughly collect data.
Actively listened to customers' requests, confirming full understanding before addressing concerns.
Developed and maintained courteous and effective working relationships.
Developed team communications and information for meetings.
High School Teacher, 03/2019 - 08/2020 Texans Can Academy – City, STATE,
Evaluated students' academic and social growth, kept appropriate records and prepared progress reports to gauge performance.
Delivered audio-visual presentations on platforms such as PowerPoint, Prezi and Google Slides.
Conferred with parents and administration about student progress.
Developed positive rapport with students of various and diverse backgrounds.
Developed materials for laboratory activities and course materials, including homework assignments and handouts to facilitate learning.
Discussed important historical figures, dates and events which helped shape modern world.
Developed communicative relationships with students and parents to support learning.
Selected and requisitioned appropriate books and instructional aids to complement lesson plans.
Used computers, audio-visual aids, and other equipment to supplement presentations.
Established and communicated clear objectives for all educational activities.
Worked with other teachers for comprehensive approach to education.
Maintained positive and professional classroom environment throughout school year.
Clinical Research Technician, 07/2017 - 03/2019 Covance Clinical Research – City, STATE,
Kept all work areas extremely clean and sanitized properly to avoid errors in research.
Supported senior management with creation and enhancement of continuous improvement of research procedures.
Reduced operational roadblocks and solved product and process issues to optimize efficiency.
Maximized efficiency by meticulously organizing and administering experiments.
Reduced project discrepancies by optimizing quality control standards.
Verified regulatory compliance and protocol adherence through comprehensive inspections.
Eliminated procedure gaps by effectively guiding and teaching Technicians on operations of machinery, inspection protocols and processes.
Assisted with training junior team members in laboratory techniques and operation of equipment.
Inputted and edited computer entries from generated research using EDC software.
Collected data and followed research protocols, operations manuals and case report form requirements.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
Maintained compliance with protocols covering patient care and clinical trial operations.
Followed informed consent processes and maintained records.
Collected, evaluated and modeled collected data.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Collaborated closely with physicians and nursing staff to improve quality of patient records documentation.
Participated in committees to discuss topics, including electronic health records and methods that would improve overall workflows.
Collected, reviewed and analyzed data from diverse departments.
Completed all paperwork, recognizing any discrepancies and addressing them in a timely fashion.
Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
Worked closely with Medical Director to maintain optimum levels of communication to effectively and efficiently complete projects.
Education
Bachelor Of Applied Science: University, Expected in 12/2016 - The University of Texas At Arlington - Arlington, TX GPA:
Associate Of Applied Science: Science, Technology, Expected in 08/2014 - Mountain View College - Dallas, TX GPA:
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