533 Providence Lane
Glendora, CA 91740
Job Objective Seeking a chance to work with a growing company through filling the Clinical Study Manager position and putting my experience to good use.
Highlights of Qualifications:
- Admirable experience in clinical research and protocols
- Exceptional knowledge of FDA and ICH guidelines
- Deep knowledge of human anatomy
- Ability to analyze data and summarize reports
- Ability to prepare presentations
- Excellent Microsoft Office skills
- Good communication skills in both oral and written forms
- Proficient to maintain computerized data systems
Clinical Study Manager
Innovation Works, Inc., Glendora, CA
October 2008 – Present
- Performed investigation on clinical trials and medical devices.
- Monitored clinical trials according to FDA requirements and regulations.
- Evaluated investigational sites and maintained data integrity.
- Managed investigator agreements and obtained required approvals.
- Trained staff for clinical trials for various investigational devices.
- Developed clinical protocols and prepared case report forms and manuals.
- Prepared clinical data summaries for FDA regulations.
- Assisted to resolve all data queries for customers.
Clinical Study Coordinator
ALung Technologies, Inc, Glendora, CA
August 2003 – September 2008
- Organized and collect data for projects and prepared reports.
- Evaluated patient records and included same in study.
- Performed quality assurance tests and maintained inventory.
- Maintained patient record and retrieved it as required.
- Analyzed statistical data and reviewed available data for study.
- Managed and analyzed data set within required timeframe.
Clinical Study Assistant
AGA Medical Corporation, Glendora, CA
May 1998 – July 2003
- Coordinated with staff members and resolved clinical and non clinical issues.
- Maintained inventory of all clinical supplies and provided purchase orders.
- Developed and maintained documents and databases.
- Participated in study meetings and prepared record of all minutes.
- Designed and maintained master files and prepared documents.
- Administered clinical project payments and distributed payments.
Bachelor’s Degree in Clinical Laboratory Science
Oglala Lakota College, Kyle, SD