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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.
- Trial management
- Research SOPs understanding
- Informed consent
- Study protocols
- Good Clinical Practices
- Training & Development
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- Multitasking abilities
- Teambuilding
- Organization and Time management
- Analytical skills
- Microsoft Office
- Planning and Coordination
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Clinical Trial Lead/Manager, 05/2021 - Current
Catapult Learning – Greenville, SC,
- Manages 15+ studies.
- 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.
Bachelor Of Applied Science: University, Expected in 12/2016
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The University of Texas At Arlington - Arlington, TX
GPA:
Associate Of Applied Science: Science, Technology, Expected in 08/2014
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Mountain View College - Dallas, TX
GPA:
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