SENIOR CLINICAL RESEARCH ASSOCIATE

GARY A. GARNER
19689 Black Olive Lane
Boca Raton, Florida 33498
Office: (561) 477-1858
Fax: (561) 483-0948
Cell: (561) 504-1108
E-mail: gg19c099@westpost.net
PROFESSIONAL OBJECTIVE:
Independently manage multiple clinical sites for various clinical studies. Take
ownership of individual site administration to assure proper planning, timely i
nitiation and completion and high quality documentation. Provide key coordinati
on role between sites and project management. Work closely with the Project Man
ager and Director to assure that protocol requirements, regulatory guidelines an
d study timelines are met. Provide close oversight, analysis of study progress
and problem-solving leadership. Assure careful review of study documents and da
ta as required by SOPs. Maintain project status and assures that Sponsor and si
tes are aware of all critical issues.
PROFESSIONAL EXPERIENCE:
2010 - Present Per Diem Senior Clinical Research Associate
Florida
June/2009 - Regional Clinical Research Associate
Dec/2009 I3 Pharma
Southeast USA and Florida.
2008 - Senior Clinical Research Associate
May/2009 Neurocrine Biosciences Inc.
San Diego, CA
2007 - 2008 Regional Senior Clinical Research Associate
PAREXEL International, LLC
Waltham, MA
2006 - 2007 Regional Clinical Research Associate
Covance, Inc.
Princeton, New Jersey
2002 - 2006 Director of Clinical Data Support
OmniComm Systems
Fort Lauderdale, Florida

1985 - 2002 Senior Clinical Research Associate II

Pharmaceutical Food & Drug Associates, Inc.
Roslyn Heights, New York
1981 - 1985 Senior Clinical Research Associate II
Procter & Gamble Company
Cincinnati, Ohio
1977 - 1981 Clinical Research Associate (CRA)
Richardson-Merrill Chemical Company (Vicks)
Westchester, New York
PROFESSIONAL SKILLS:
* Perform routine site visits, including prequalification visits, site
Initiation visits and routine monitoring visits.
* Manage assigned sites to ensure sites compliance, adequate enrollment and unde
rstanding of protocol requirements.
* Independently manage/monitor sites to ensure all clinical trials activities a
re in accordance with protocol plus GCP/ICH regulations and statues
* Conduct periodic audits of study files for record management
* Ensure proper distribution, storage and accountability of study
Supplies
* Manage assigned sites to ensure site compliance, adequate
Enrollment and understanding of study requirements
* Provide Training of new Clinical Researc
h Associates and
Field Monitors
h Conduct study close-out visits
* Verification of regulatory documents
* Assure compliance with GCP, ICH and Sponsors SOP's
h Facilitating communication between Investi
gative site and
Sponsor
h Resolving data clarifications with the sit
es
EDUCATION:
1979 Institute for Applied Pharmaceutical Sciences
East Brunswick, New Jersey
1973 - 1977 B.S. Biochemistry
The American University
Washington, D.C.

Therapeutic Areas:
Analgesic, Anti-Infective, Cardiovascular (Beta Blocker/Calcium Channel Blocker/
ACE, Diabetes (Type II), CNS (Depression/MDD/Alzheimer's), Dermatology, Endocrin
e, Gastroenterology, OB/GYN (Woman Health/Endometriosis/ Birth Control, STD), Ne
urological Diseases (Epilepsy/Alzheimer/Parkinson), Ophthalmology (Dry eye/IOL),
Oncology (Small Cell Lung/Breast/Prostate), Pain Management, Pulmonary (COPD, A
sthma), Psychiatry (Benzodiazepine), Sepsis, Vaccines ( HPV)