REGIONAL SENIOR CLINICAL RESEARCH ASSOCIATE GARY ALAN GARNER 19689 Black Olive L

ane Boca Raton, Florida 33498 (561) 477-1858 (O) (561) 504-1108 (C) (561) 483-09
48 (F) gg1057e0a@westpost.net SUMMARY OF QUALIFICATION a Independently manage mu
ltiple clinical sites for various clinical studies. a Take ownership of individu
al site administration to assure proper planning, ti mely initiation and complet
ion and high quality documentation. a Provide key coordination role between site
s and project management. a Work closely with the Project Manager and Director t
o assure that protocol req uirements, regulatory guidelines and study timelines
are met. a Provide close oversight, analysis of study progress and problem-solvi
ng 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 a a a a a a a a a a a a a
a a a Analgesic Anti-Infective Cardiovascular (Beta Blocker/Calcium Channel Blo
cker/ACE) Diabetes (Type II) CNS (Depression/MDD/Alzheimeras) Dermatology Endocr
ine Gastroenterology OB/GYN (Woman Health/Endometriosis/ Birth Control/STD/Migra
ines) Neurological Diseases (Epilepsy/Alzheimer/Parkinson/Migraines) Ophthalmolo
gy (Dry eye/IOL) Oncology (Small Cell Lung/Breast/Prostate) Pain Management Pulm
onary (COPD, Asthma) Psychiatry (Benzodiazepine) Sepsis Vaccines (HPV)
PROFESSIONAL EXPERIENCE PRA International, Raleigh, NC Oct/2010 a" Present TA: A
lzheimer Disease (Phase III/Aug/2010 a" Present) Regional Clinical Research Asso
ciate a Perform routine site visits, including prequalification visits, site Ini
tiatio 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 Associat
e a Perform routine site visits, including prequalification visits, site Initiat
io n visits and routine monitoring visits. Neurocrine Biosciences Inc., San Dieg
o, CA Jan/2008 - May/2009 TA: Endometriosis (Phase II/ Jan 2008 - May 2009) Regi
onal 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 und
e rstanding of protocol requirements. a Independently manage/monitor sites to en
sure all clinical trials activities a re in accordance with protocol plus GCP/IC
H regulations and statues a Conduct periodic audits of study files for record ma
nagement a Ensure proper distribution, storage and accountability of study Suppl
ies 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 Fac
ilitating 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 (Phas
e I/ Feb 2007 a" Nov 2007) Diabetes - Type II (Phase III/ Jan 2007 - Dec 2007) A
utoimmune Disease - Lupus (Phase II/Mar 2007 a" Dec 2007) Migraines (Phase II/Ja
n 2007 a" Dec 2007) Regional Senior Clinical Research Associate a Design, Conduc
t and Management of Phase 1-4 clinical trials a Independently manage/monitor sit
es to ensure all clinical trials activities a re in accordance with protocol plu
s GCP/ICH regulations and statues a a a a a a a a Conduct periodic audits of stu
dy files for Record Management Ensure proper distribution, storage and accountab
ility of study Supplies: Manage assigned sites by regular contacts to ensure sit
e Compliance, adequate enrollment and understanding of study Conduct study close
-out visits Verification of regulatory documents Facilitating communication betw
een Investigative site and Sponsor Resolving data clarifications with the sites
Covance, Inc., Princeton, New Jersey Feb/2006 - Dec/2006 TA: Small Cell Lung Can
cer (Phase II/Feb 2006 a" Dec 2006) Deep Venous Thrombosis a" DVT (Phase III/ Fe
b 2006 a" Dec 2006) Cardiovascular a" Stents (Phase II/ Feb 2006 a" Dec 2006) Pu
lmonary a" COPD (Phase II/ Mar 2006 a" Dec 2006) Migraines a" Pain Management (P
hase II/ Feb 2006 a" Dec 2006) Regional Clinical Research Associate a Conduct al
l types of monitoring visits which includes all preparatory and foll

ow up aspects. a Independently manage/monitor sites to ensure all clinical trial

s activities ar e in accordance with protocol plus GCP/ICH regulations and statu
es a Conduct periodic audits of study files for Record Management a Confirm prop
er distribution, storage and accountability of study a Manage assigned sites by
regular contacts to ensure site a Compliance, adequate enrollment and understand
ing of study a requirements a Update project management at least weekly with stu
dy progress and issues that need clarification. a Verification of regulatory doc
uments a Facilitating communication between Investigative site and Sponsor a Res
olving protocol deviations with site and data management OmniComm Systems, Fort
Lauderdale, Florida May/2002 a" Jan/2006 Director of Clinical Data Support a Ass
ist 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 t
raining 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 technica
l 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 (P
hase II a" III/ Jan 1985 a" Dec 2001) Analgesic a" Pain Management (Phase I a" I
V/ 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" Alzhe
imer (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 investigat
ional site performance a Accurately completed SAE forms for various Sponsors a W
orked with Clinical Trial Pharmacists to maintain study drug as per GCP, FDA and
ICH guidelines a Product Development a Marketing Coordinator a Supervisor of Cl
inical Staff a Grant Administrator a Regulatory Affairs a Post Marketing Surveil
lance a Quality Assurance Audits a Quality of Life Studies a Served as liaison b
etween Investigative site and Sponsor a Review CRFs and source documents for acc
uracy Procter & Gamble Company, Cincinnati, Ohio Jan/1981 - Jan.1985 Senior Clin
ical Research Associate II a Protocol Design a Case Record Form Design a interpr
etation of Data (Final Report)

a a a a
Product Conduct Conduct Conduct
Development study qualification visit study initiation visit periodic audits of
study files for Records Management
Richardson-Merrill Chemical Company (Vicks), Westchester, New York Sep/1977 a" J
an/1981 Clinical Research Associate (CRA) a Conduct monitoring visits a Facilita
ted 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 Unive
rsity, Washington, D.C. B.S. Biochemistry, 1973 a" 1977

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