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)
SUMMARY OF QUALIFICATION
* Independently manage multiple clinical sites for various clinical studies.
* Take ownership of individual site administration to assure proper planning, t
imely initiation and completion and high quality documentation.
* Provide key coordination role between sites and project management.
* Work closely with the Project Manager and Director to assure that protocol re
quirements, regulatory guidelines and study timelines are met.
* Provide close oversight, analysis of study progress and problem-solving leade
rship.
* Assure careful review of study documents and data as required by SOPs.
* Maintain project status and assures that Sponsor and sites are aware of all c
ritical issues.
THERAPEUTIC AREA EXPERIENCE
* Analgesic
* Anti-Infective
* Cardiovascular (Beta Blocker/Calcium Channel Blocker/ACE)
* Diabetes (Type II)
* CNS (Depression/MDD/Alzheimer's)
* Dermatology
* Endocrine
* Gastroenterology
* OB/GYN (Woman Health/Endometriosis/ Birth Control/STD/Migraines)
* Neurological Diseases (Epilepsy/Alzheimer/Parkinson/Migraines)
* Ophthalmology (Dry eye/IOL)
* Oncology (Small Cell Lung/Breast/Prostate)
* Pain Management
* Pulmonary (COPD, Asthma)
* Psychiatry (Benzodiazepine)
* Sepsis
* Vaccines (HPV)
PROFESSIONAL EXPERIENCE
I3 Pharma, Basking Ridge, NJ
June/2009 - Present
TA: Migraines (Phase II/ June 2009 - Dec 2009)
Pelvic Inflammatory Disease -PID (Phase III/ Jan/ 2010 - May 2010)
Per Diem Regional Clinical Research Associate
* Perform routine site visits, including prequalification visits, site Initiati
on 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
* Perform routine site visits, including prequalification visits, site
* Initiation visits and routine monitoring visits
* Manage assigned sites to ensure sites compliance, adequate enrollment and und
erstanding 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 Mana
ge assigned sites to ensure site compliance, adequate
* Enrollment and understanding of study requirements
* Provide Training of new Clinical Research Associates and Field Monitors
* Conduct study close-out visits
* Verification of regulatory documents
* Assure compliance with GCP, ICH and Sponsors SOP's
* Facilitating communication between Investigative site and Sponsor
* Resolving data clarifications with the sites
PAREXEL International, LLC, Waltham, MA
Jan/2007 - Dec/2007
TA: Human Papillomavirus (Phase III/Jan 2007 - Sep 2007)
Sepsis (Phase I/ Feb 2007 - Nov 2007)
Diabetes - Type II (Phase III/ Jan 2007 - Dec 2007)
Autoimmune Disease - Lupus (Phase II/Mar 2007 - Dec 2007)
Migraines (Phase II/Jan 2007 - Dec 2007)
Regional Senior Clinical Research Associate
* Design, Conduct and Management of Phase 1-4 clinical trials
* 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 by regular contacts to ensure site
* Compliance, adequate enrollment and understanding of study
* Conduct study close-out visits
* Verification of regulatory documents
* Facilitating communication between Investigative site and Sponsor
* Resolving data clarifications with the sites
Covance, Inc., Princeton, New Jersey
Feb/2006 - Dec/2006
TA: Small Cell Lung Cancer (Phase II/Feb 2006 - Dec 2006)
Deep Venous Thrombosis - DVT (Phase III/ Feb 2006 - Dec 2006)
Cardiovascular - Stents (Phase II/ Feb 2006 - Dec 2006)
Pulmonary - COPD (Phase II/ Mar 2006 - Dec 2006)
Migraines - Pain Management (Phase II/ Feb 2006 - Dec 2006)
Regional Clinical Research Associate
* Conduct all types of monitoring visits which includes all preparatory and fol
low up aspects.
* 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
* Confirm proper distribution, storage and accountability of study
* Manage assigned sites by regular contacts to ensure site
* Compliance, adequate enrollment and understanding of study
* requirements
* Update project management at least weekly with study progress and issues that
need clarification.
* Verification of regulatory documents
* Facilitating communication between Investigative site and Sponsor
* Resolving protocol deviations with site and data management
OmniComm Systems, Fort Lauderdale, Florida
May/2002 - Jan/2006
Director of Clinical Data Support
 * Assist in storage of clinical data utilizing Electronic Data
* Capture in compliant to 21 CFR Part II
* Clinical Trial Management
* Data Collection and Validation
* Local and central laboratory capture and batch data loading
* Provide onsite training to personnel in the handling of
* EDC storage including login, security, data entry and data review
* Clinical study support globally with 24/7 technical support
Pharmaceutical Food & Drug Associates, Inc., Roslyn Heights, New York
Jan/1985 - March/2002
TA: Diabetes - Type II (Phase 1 - III/ Feb 1985 - Oct 1989)
Cardiovascular (Phase II - IV/ Apr 1985 - Feb 2002)
Pulmonary - COPD (Phase II - III/ Jan 1985 - Dec 2001)
Analgesic - Pain Management (Phase I - IV/ Feb 1985 to Jan 2002)
Gastroenterology (Phase II - III/ Jan 1985 to Dec 2001)
Oncology- Breast Cancer/Prostate (Phase II/ May 1985 - Dec 1998)
CNS - Alzheimer (Phase 1 - II/ Jan 1989 - Mar 2002)
Depression (Phase I to III/ Jan 1986 - Jan 2002)
Senior Clinical Research Associate II
* Assessed overall investigational site performance
* Accurately completed SAE forms for various Sponsors
* Worked with Clinical Trial Pharmacists to maintain study drug as per GCP, FDA
and ICH guidelines
* Product Development
* Marketing Coordinator
* Supervisor of Clinical Staff
* Grant Administrator
* Regulatory Affairs
* Post Marketing Surveillance
* Quality Assurance Audits
* Quality of Life Studies
* Served as liaison between Investigative site and Sponsor
* Review CRFs and source documents for accuracy
Procter & Gamble Company, Cincinnati, Ohio
Jan/1981 - Jan.1985
Senior Clinical Research Associate II
* Protocol Design
* Case Record Form Design
* interpretation of Data (Final Report)
* Product Development
* Conduct study qualification visit
* Conduct study initiation visit
* Conduct periodic audits of study files for Records Management
Richardson-Merrill Chemical Company (Vicks), Westchester, New York
Sep/1977 - Jan/1981
Clinical Research Associate (CRA)
* Conduct monitoring visits
* Facilitated IRB submissions
* Provided Sponsor with follow-up information on all SAEs in a timely fashion
* 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 - 1977