Clinical Research Resume Sample Two

999 Main Street, Any Town, NY 99999
Mobile: (999) 999-9999
Email: email@yahoo.com

Paul Harris

Seeking a challenging position in the field of clinical research in the pharmaceutical industry.

Bachelor’s 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.

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 activities.
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.

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.
Identified, 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.