Elisabeth Dapor
Dallas,TX
Summary
I have been involved in clinical trials for13 years . My experience started as a study coordinator and includes project management positions . I have extensive knowledge and experience in all phases as well as broad spectrum of therapeutic areas
Overview
12
12
years of professional experience
Work History
Clinical Research Associate
Velox Medical center
03.2019 - 03.2023
- Review and or input to study protocol,CRF and validation tools
- Preparation and review of study documents,monitoring guides,CRF completion guidelines, patient information and informed content
- prepare the submission to independent ethics committees(central and local) when applicable to regulatory authorities
- Conducts site qualification visits
- Conducts site initiation visits
- Responsible for quality of data for his/her own sites
- Resolves and writes data clarification forms and review data listing
- Maintain close contacts with investigator onsite, the centre study coordinator ,the pharmacists and other involved parties to be aware of any possible patients enrollments, the enroll patients status, IP stock and any other site requests and problems
- Filing and update of update of study documentation in the investigator site file and pharmacy file (if applicable) and the TMF within the clinical office through out the study
Senior Clinical Research Associate
Merck
10.2015 - 11.2018
- Regional CRA for phase III double blind study with Merck
- Conducts selection visits,pre-study,initiation,interim,pre-closeout and Close out site visit
- Responsible for IRB/EC submissions for all central sites
- Preparation of Regulatory,CRA and SAE manual
- Retrieval and and processing of regulatory documents for clinical studies
- Generate and process confidentiality agreements, financial agreements and financial disclosure
- Quality control review of medical history charts,source documents and case report forms, as well as corresponding laboratory samples,laboratory reports, and ECG reports,DEXA reports including query generation and solution
- Review,track and submit all serious adverse events to safety desk or sponsor
CRA
Institute Of Human Virology, Ihvn
03.2011 - 12.2014
- Participated in and facilitated cross-functional study teams,
- liaised with other functional areas to accurately coordinate clinical study activities.
- Coordinated clinical study timelines with Project management to meet critical milestones; escalated issues that may jeopardize timelines and deliverables.
- Provided monitoring oversight by reviewing monitoring schedules, metrics and reports.
- Accurately updated and maintained clinical systems within project timelines.
- • Provided regular updates of study progression to superiors and other stakeholders.
- Proactively identified and resolved issues that arise during study and manage escalation of study-related issues.
- Implemented appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintained clinical study files per ICH guidance.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Education
GCP - Good clinical Practice
National Drug Abuse Treatment of Clinical Trials
USA06.2023
B. Agric - Agric Economics
Federal University of Agriculture
11.2010
Skills
Computer skills
CTMS
ECRF
Microsoft office
EDC
TMF
General skills
Protocol development
Affiliations
Therapeutic Area of Expertise
Therapeutic Areas Experience
- Cardiology/Vascular diseases Research and Development
- Radio Pharmaceuticals Research and development
- Hypertension Research and Development
- Vaccine Research and Development
- Hematological Research and Development
- Pediatric Research and Development
- Psychiatry/Psychology Research and Development
- Pulmonary/Respiratory Research and Development
- Rare Disease Research and Development
- Urology Research and Development
- Oncology Research and Development
- Medical Device Research and Development
- Radiotherapy Research and Development
Timeline
Clinical Research Associate
Velox Medical center
03.2019 - 03.2023
Senior Clinical Research Associate
Merck
10.2015 - 11.2018
CRA
Institute Of Human Virology, Ihvn
03.2011 - 12.2014
GCP - Good clinical Practice
National Drug Abuse Treatment of Clinical Trials
B. Agric - Agric Economics
Federal University of Agriculture
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