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REGIONAL SENIOR CLINICAL RESEARCH ASSOCIATE

GARY ALAN GARNER


19689 Black Olive Lane
Boca Raton, Florida 33498
(561) 477-1858 (O)
(561) 504-1108 (C)
(561) 483-0948 (F)
gg1057e0a@westpost.net

SUMMARY OF QUALIFICATION
a Independently manage multiple clinical sites for various clinical studies.
a Take ownership of individual site administration to assure proper planning, ti
mely initiation and completion and high quality documentation.
a Provide key coordination role between sites and project management.
a Work closely with the Project Manager and Director to assure that protocol req
uirements, regulatory guidelines and study timelines are met.
a Provide close oversight, analysis of study progress and problem-solving leader
ship.
a Assure careful review of study documents and data as required by SOPs.
a Maintain project status and assures that Sponsor and sites are aware of all cr
itical issues.
THERAPEUTIC AREA EXPERIENCE
a Analgesic
a Anti-Infective
a Cardiovascular (Beta Blocker/Calcium Channel Blocker/ACE)
a Diabetes (Type II)
a CNS (Depression/MDD/Alzheimeras)
a Dermatology
a Endocrine
a Gastroenterology
a OB/GYN (Woman Health/Endometriosis/ Birth Control/STD/Migraines)
a Neurological Diseases (Epilepsy/Alzheimer/Parkinson/Migraines)
a Ophthalmology (Dry eye/IOL)
a Oncology (Small Cell Lung/Breast/Prostate)
a Pain Management
a Pulmonary (COPD, Asthma)
a Psychiatry (Benzodiazepine)
a Sepsis
a Vaccines (HPV)

PROFESSIONAL EXPERIENCE
PRA International, Raleigh, NC
Oct/2010 a" Present
TA: Alzheimer Disease (Phase III/Aug/2010 a" Present)
Regional Clinical Research Associate
a Perform routine site visits, including prequalification visits, site Initiatio
n visits and routine monitoring visits.
I3 Pharma, Basking Ridge, NJ
June/2009 - Present
TA: Migraines (Phase II/ June 2009 a" Dec 2009)
Pelvic Inflammatory Disease -PID (Phase III/ Jan/ 2010 a" May 2010)
Per Diem Regional Clinical Research Associate
a Perform routine site visits, including prequalification visits, site Initiatio
n visits and routine monitoring visits.
Neurocrine Biosciences Inc., San Diego, CA
Jan/2008 - May/2009
TA: Endometriosis (Phase II/ Jan 2008 - May 2009)
Regional Senior Clinical Research Associate
a Perform routine site visits, including prequalification visits, site
a Initiation visits and routine monitoring visits
a Manage assigned sites to ensure sites compliance, adequate enrollment and unde
rstanding of protocol requirements.
a Independently manage/monitor sites to ensure all clinical trials activities a
re in accordance with protocol plus GCP/ICH regulations and statues
a Conduct periodic audits of study files for record management
a Ensure proper distribution, storage and accountability of study Supplies
Manage assigned sites to ensure site compliance, ad
equate
a Enrollment and understanding of study requirements
a Provide Training of new Clinical Research Associates and Field Monitors
a Conduct study close-out visits
a Verification of regulatory documents
a Assure compliance with GCP, ICH and Sponsors SOPas
a Facilitating communication between Investigative site and Sponsor
a Resolving data clarifications with the sites
PAREXEL International, LLC, Waltham, MA
Jan/2007 a" Dec/2007
TA: Human Papillomavirus (Phase III/Jan 2007 - Sep 2007)
Sepsis (Phase I/ Feb 2007 a" Nov 2007)
Diabetes - Type II (Phase III/ Jan 2007 - Dec 2007)
Autoimmune Disease - Lupus (Phase II/Mar 2007 a" Dec 2007)
Migraines (Phase II/Jan 2007 a" Dec 2007)
Regional Senior Clinical Research Associate
a Design, Conduct and Management of Phase 1-4 clinical trials
a Independently manage/monitor sites to ensure all clinical trials activities a
re in accordance with protocol plus GCP/ICH regulations and statues
a Conduct periodic audits of study files for Record Management
a Ensure proper distribution, storage and accountability of study
a Supplies: Manage assigned sites by regular contacts to ensure site
a Compliance, adequate enrollment and understanding of study
a Conduct study close-out visits
a Verification of regulatory documents
a Facilitating communication between Investigative site and Sponsor
a Resolving data clarifications with the sites
Covance, Inc., Princeton, New Jersey
Feb/2006 - Dec/2006
TA: Small Cell Lung Cancer (Phase II/Feb 2006 a" Dec 2006)
Deep Venous Thrombosis a" DVT (Phase III/ Feb 2006 a" Dec 2006)
Cardiovascular a" Stents (Phase II/ Feb 2006 a" Dec 2006)
Pulmonary a" COPD (Phase II/ Mar 2006 a" Dec 2006)
Migraines a" Pain Management (Phase II/ Feb 2006 a" Dec 2006)
Regional Clinical Research Associate
a Conduct all types of monitoring visits which includes all preparatory and foll
ow up aspects.
a Independently manage/monitor sites to ensure all clinical trials activities ar
e in accordance with protocol plus GCP/ICH regulations and statues
a Conduct periodic audits of study files for Record Management
a Confirm proper distribution, storage and accountability of study
a Manage assigned sites by regular contacts to ensure site
a Compliance, adequate enrollment and understanding of study
a requirements
a Update project management at least weekly with study progress and issues that
need clarification.
a Verification of regulatory documents
a Facilitating communication between Investigative site and Sponsor
a Resolving protocol deviations with site and data management
OmniComm Systems, Fort Lauderdale, Florida
May/2002 a" Jan/2006
Director of Clinical Data Support
a Assist in storage of clinical data utilizing Electronic Data
a Capture in compliant to 21 CFR Part II
a Clinical Trial Management
a Data Collection and Validation
a Local and central laboratory capture and batch data loading
a Provide onsite training to personnel in the handling of
a EDC storage including login, security, data entry and data review
a Clinical study support globally with 24/7 technical support

Pharmaceutical Food & Drug Associates, Inc., Roslyn Heights, New York
Jan/1985 a" March/2002
TA: Diabetes a" Type II (Phase 1 a" III/ Feb 1985 a" Oct 1989)
Cardiovascular (Phase II a" IV/ Apr 1985 a" Feb 2002)
Pulmonary a" COPD (Phase II a" III/ Jan 1985 a" Dec 2001)
Analgesic a" Pain Management (Phase I a" IV/ Feb 1985 to Jan 2002)
Gastroenterology (Phase II a" III/ Jan 1985 to Dec 2001)
Oncology- Breast Cancer/Prostate (Phase II/ May 1985 a" Dec 1998)
CNS a" Alzheimer (Phase 1 a" II/ Jan 1989 a" Mar 2002)
Depression (Phase I to III/ Jan 1986 a" Jan 2002)
Senior Clinical Research Associate II
a Assessed overall investigational site performance
a Accurately completed SAE forms for various Sponsors
a Worked with Clinical Trial Pharmacists to maintain study drug as per GCP, FDA
and ICH guidelines
a Product Development
a Marketing Coordinator
a Supervisor of Clinical Staff
a Grant Administrator
a Regulatory Affairs
a Post Marketing Surveillance
a Quality Assurance Audits
a Quality of Life Studies
a Served as liaison between Investigative site and Sponsor
a Review CRFs and source documents for accuracy
Procter & Gamble Company, Cincinnati, Ohio
Jan/1981 - Jan.1985
Senior Clinical Research Associate II
a Protocol Design
a Case Record Form Design
a interpretation of Data (Final Report)
a Product Development
a Conduct study qualification visit
a Conduct study initiation visit
a Conduct periodic audits of study files for Records Management
Richardson-Merrill Chemical Company (Vicks), Westchester, New York
Sep/1977 a" Jan/1981
Clinical Research Associate (CRA)
a Conduct monitoring visits
a Facilitated IRB submissions
a Provided Sponsor with follow-up information on all SAEs in a timely fashion
a Complete monitoring reports
EDUCATION
Institute for Applied Pharmaceutical Sciences, East Brunswick, New Jersey
June/1979
The American University, Washington, D.C.
B.S. Biochemistry, 1973 a" 1977

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