421 N Seventh St
Melrose, MA 02176
Job Objective To obtain a Contract Clinical Research Associate position in a company that provides an open environment with many opportunities for continuous growth.
Remarkable experience in supporting clinical research
In-depth knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
Sound knowledge of clinical research monitoring
Deep knowledge of device operation and the ability to apply clinical study processes
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), and email
Exceptional knowledge of guidelines, and systems for clinical trial management
Proven organizational, record retention, decision making and time management skills
Through attention to detail and high standard of accuracy, integrity
Excellent verbal and written communication skills
Contract Clinical Research Associate, August 2005 to till date
Apollo Productions, Melrose, MA
- Ensured to timely resolve issues and questions that arise at the study sites.
- Managed daily central lab (ICON) omissions at the subject sample level.
- Collaborated with the CRO teams, vendors, and QA to resolve oversight of provision of study supplies to clinical sites.
- Reported the logistics of study conduct by country.
- Demonstrated liaison with other third-party vendors as needed.
- Accomplished to track patient visit status to timeline, ensuring timely and accurate site performance and reported from vendor to company.
Contract Clinical Research Associate, May 2000 to July 2005
Maria Productions, Melrose, MA
- Focused on tracking grant payments and study supplies.
- Ensured the updating of clinical operations tracking systems.
- Conducted periodic monitoring activities with the investigative sites, including reviewing case report forms.
- Modified and developed Case Report Forms.
- Collected and verified essential regulatory documents, and site personnel training.
- Conducted in-house monitoring of adverse experiences and other functions required for managing clinical trial conduct.
Bachelor of Science in Nursing, Ohio Dominican University, Ohio, OH