Clinical Research Manager
Resume:
Clemance Brotschol
Union, NJ *****
********@*****.***
Summary
Responsible, determine and seasoned Clinical Research Coordinator with a track record of managing numerous successful clinical trials for many years with an inflow of 800 human subjects on a daily basis. Keeping projects organized and completing tasks as per client specifications. Excellent knowledge of industry changes in research of various cosmetics, personal cares, toiletries, OTC, fabrics and fibers for efficacy and safety. Handle assignments with accuracy and efficiency along with credentials of achieving exceptional results of various projects.
Skills
Excellent attention to details
Comprehensive understanding of regulations
Provides accurate and timely results
Strong interpersonal and organization skills
Exhibits intensity in completing work objectives
Accustomed to meeting critical deadlines while exceeding job expectations
Bilingual; fluent in French/Creole
Proficient in administrative software applications
Experience
Clinical Research Laboratories 2006 -present
Clinical Research Coordinator
Coordinate every aspect of the study as project manager from start to finish, adhering to Good Clinical Practices (GCP) as well as Standard Operating Procedures (SOPs).
Determine the eligibility and recruitment of study participants in conformance to requirements specified in the study protocols.
Complete study documentation and maintain study files including but not limited to obtaining medical histories, informed consent forms, raw data, case report forms and questionnaire responses.
Work closely with Quality Assurance (QA), reviewing and revising documents for auditing purposes.
Interact regularly with the principal investigator as well as assisting study physicians with assessments and examinations ensuring patient safety and adherence to proper study conduct.
Prepare study documentation including study protocol to be sent to and reviewed by the Institutional Review Board (IRB) and test articles to be dispensed to patient.
Record observations, test results, physical and instrumental (Visia, Chromameter and Corneometer) measurements as required.
Tabulate of test results, calculating and summarizing.
Perform follicular biopsies as well as special procedures as qualified by training and evaluation of proficiency.
Maintain product accountability and preparing for archiving or returning to Sponsors.
Assist in training of new clinical staff.
Education
Bachelor of Science Biology Bloomfield College Bloomfield, NJ
Certification
ASHI Approved CPR PRO Certified 2017
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