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Yyyyyy x. yyyyyy
0000 xxxxxx xxxx , xxxx , xxxxx 00000 abc@xyz.com xxx-xxx-xxxx
Experienced Strategic Leader with several years of experience in high-stress environments along with a strong background in project management/coordination roles. Experienced in managing day-to-day administrative operations, implementing research project best practices, and managing quality related functions. Equipped with a significant level of communication and interpersonal abilities in addition to a strong background in effectively fostering positive relationships with others.
Proficient in: Microsoft Office Suite, Lotus, IVRS, EDC, eClinical, CTMS, and IMPACT
Key Competencies
Clinical Research Coordination Project Management Quality Control Best Practices Strategy Development |
Regulatory Compliance Complex Problem Solving Training/Coaching Requirements Analysis |
Process Improvement Attention to Detail Team Leadership Timeline Management
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Professional Experience
RHO, Research Organization 2014
Clinical Research Associate II
- Directly managed a variety of administrative and operational functions within a fast-paced environment with a focus on completing in-depth research related to clinical trials
- Visited participants throughout various stages of the trial, compiled in-depth visit reports, and utilized superior analytical abilities in order to evaluate the integrity of study policies and procedures
- Instrumental in several project management functions which included identifying project/study requirements, adhering to study related regulations, and completing study audits
- Researched and resolved study related issues, played a key role in the monitoring of both adverse events and serious adverse events investigations, and documented study/site progress
Children s Hospital of Philadelphia (CHOP) September 2006-July 2014
Clinical Research Associate (2009-2014)
- Guided the day to day management and management of various clinical research projects which included reviewing performing quality checks and identifying/correcting issues
- Completed study related visits which included both pre-study, site initiation, interim site, and close-out visits along with monitoring regulatory compliance tasks
- Oversaw investigator compliance during the reporting of both adverse events and serious adverse events in addition to maintaining electronic data systems (Inform, Rave, eTrials)
- Prepared reports related to study site issues, study progress, and other metrics along with creating comprehensive schedules in order to meet deadlines
Clinical Research Coordinator (2008-2009)
- Instrumental in the completion of large-scale projects which required superior analytical, time management, and scheduling abilities
- Performed complex statistical analysis, developed study related presentations, and coordinated grant proposal submissions along with training both medical and clinical staff members
- Maintained a keen knowledge of IRB, FDA, ICH, and GCP (good clinical practices/best practices
Yyyyyy x. yyyyyy
0000 xxxxxx xxxx , xxxx , xxxxx 00000 abc@xyz.com xxx-xxx-xxxx
Professional Experience Continued:
Psychiatric Care Specialist (2006-2008)
- Utilized superior communication and interpersonal abilities in order to maintain positive rapport with both patients and families along with successfully identifying patient care priorities based on patient medical needs and departmental requests
- Created and implemented both standard operating procedures and practice goals/metrics which were concentrated on achieving departmental goals
Education/Certifications
Bachelor of Science, Political Science and Public Administration, University of Benin
Project Management Training Certification
Business Analyst Training Certificate
Completed Training Includes: Introduction to Practical Clinical Project Management, Safety Reporting Guidelines, GCP ICH Training, Clinical Documentation & Terminology Training, Clinical Research Monitoring Training, Data Information Management Training, IMPACT Training, and Oncology Modules I&II Training
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