999 Main Street, Any Town, NY 99999
Mobile: (999) 999-9999
Seeking a challenging position in the field of clinical research in the pharmaceutical industry.
- degree in the field of medicine.
- Total of 10 years experience in health care industry performing Clinical Research and statistical data analysis using various software tools.
- Extensive experience in data analysis using SAS Base, SAS-STAT, SAS-GRAPH, SAS-MACRO, SAS Enterprise Guide, SPSS, Sigma Stat, Sigma Plot, MS Excel and MS ACCESS database.
- Knowledge of regulatory requirements concerning industry technical.
- Knowledge of areas of CDISC, Electronic Data Capture (EDC) and Safety Reporting.
- Extensive knowledge of drug, device development process, human path physiology and diseases.
- Experience in the field of Information Technology including database development, computer programming and using web as a research and productivity tool in the medical field.
ABC Inc. Associate Research Coordinator, Aug 07 – Present
- Dietary Intervention Study in Children (DISC).
- Trials of Hypertension Prevention (TOHP).
- Women’s Health Initiative (WHI).
- Excel Breast Cancer Prevention Study (Map.3).
XYZ Corp., Clinical Research Coordinator, Jan 02 – Apr 07
- Coordination of clinical trials.
- Verify subject safety and adherence to FDA Regulations and ICH, GCP Guidelines.
- Ensure Adverse Events are reported appropriately, accurately and in a timely manner and follow-up .
- Complete CRF, ECRF data entry, Informed Consent Documents and review query language and narratives.
- Acquire specific clinical and therapeutic knowledge related to studies conducted.
- Conduct Pre-study, Initiation, Interim and Closeout visits.
- Ensure complete and thorough study drug reconciliation.
- Monitor data of clinical research coordinators.
- Work directly with CRA assisting monitoring and close-out visits.
- Assist with budgets and contracts.
BCD Inc. Clinical Research Nurse, Jun 99 – Oct 00
- Involved in Quality Assurance, developed guidelines and made changes as needed based on lessons learned.
- Responsible for: user acceptance testing; initializing and scheduling of studies; local administrator rights; troubleshooting; review of all data collected to ensure completeness.
- Presented upcoming study previews and post results to immediate and supporting staff to improve communication.
- Created many Standard Operating Procedures (SOP’s).
- Frequently asked to advice on hiring decisions.
- Initiated and created new hire training and orientation packets to ensure standardized and thorough training.
- , trained and coached under performing staff to improve department quality.
Languages: Visual Basic, Java
Software: SAS Base, SAT, STAT, SAS, GRAPH, SAS, MACRO, SAS Enterprise Guide, MS Office, MS ACCESS
OS: Microsoft Windows NT, Mac OS
B.S., Medicine, University of Utah, May 99
Computer Programming Classes, GPA 4.0, Oakland and Ma comb Community College.