Scott W. Maurer
14565 Candy Way Delray Beach, Florida 33484 (561) 372-8497 cell:(561) 862-8245
Email: ocrhawaii@aol.com
Website: www.drug-research.com
1994 – Present - CONSULTING - dba – “Oncology Clinical Research”
RESPONSIBILITIES INCLUDED:
Project Management, Field Monitoring, GCP Auditing for Phase I-IV clinical trials; performing site selection/recruitment visits,
investigator meeting presentations, study start-up, initiation, interim and close-out monitoring visits, CRF data review,
medical/protocol and SOP writing, patient safety data review and reporting, ICD-9, WHO/ART coding, CRA training/mentoring,
regulatory submission writing, timeline/financial management, budget negotiations, on-site medical surveillance, study budget
administration, timeline assurance, CRO/CRA oversight and evaluation. Provided site level patient recruitment advisement and
implementation, study problem resolutions, CAPA implementation, management safety reporting and CIOMS report preparations.
THERAPEUTIC EXPERIENCE
Aids
Phases 1-111
Anti-Infective
Phases 11-1V
Cardiovascular
Phases1-1V
CNS
Phases 1-1V
Devices
IDE/510K
510K
GI
Phases 1-111
Infectious Dis
Phase111-1V
Oncology
Phases 1-1V
Phases 1-111
Phases 1-1V
Ophthalmology Phases 1-11
Phase II
Respiratory
Phases1-111
Pain
Phases1-111
Reproductive
Phase 111
Transplantation Phase 111
CMV, KS, PCP
UTI, URI, topical wounds
HTN, Stroke, MI
ALZ, Depression
Asthma, Hemostasis/pain
Cardiac Stent
GERD, surgical pain
SARS, HEP -C
MM, Leukemia, H Cal,
Lymphoma, Melanoma
Solid Tumors, Lung, PC
Dry- eye, Retinitis,
Macular Degeneration
Allergy, Asthma
Bone, surgical
Abortion
Kidney, Liver, Sm bowel
Biologic/Pharmaceutical
Biologic/Pharmaceutical
Biologic/Pharmaceutical
Pharmaceutical
Medical Device
Medical Device
Pharmaceutical/OTC
Pharmaceutical
Biologic/Pharmaceutical
Biologic/Pharmaceutical
Biologic/Pharmaceutical
Pharmaceutical
Pharmaceutical
Pharmaceutical
Pharmaceutical
Pharmaceutical
Pharmaceutical
CRO
Pharma/CRO
Pharma/CRO
CRO
Device Co.
CRO
Pharma
Pharma
Pharma/CRO
Pharma/CRO
Pharma/CRO
Pharma/CRO
Pharma/CRO
Pharma/CRO
Pharma/CRO
CRO
Pharma
3yrs
2yrs
5yrs
3yrs
2yrs
1yr
2yrs
3yrs
6yrs
2yrs
5yrs
1yr
2yrs
2yrs
3yrs
2yrs
2yrs
SKILL SETS
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Phase 1 Monitoring – PK, PD, crossover, steady-state and specialized studies
Field Monitoring and CRO oversight- Phases 1-1V startup, initiation, interim, closeout
EDC training and mentoring both for staff and site personnel
Problem solving and creative solutions for site and patient recruitment challenges
Presentations - Protocol, Data analysis at Investigator meetings, sites, poster sessions
Management of Trial Master Files and site budgets – contract negotiations, payments
Data review, safety reporting and clean-up operations, study drug reconciliation
Technical writing - Protocols, CRFs, SOP’s, clinical reports, regulatory submissions
Documentation of deficiencies in protocol execution, patient entry and ICF versions
In-house audit of SOP compliance at sponsor and CRO levels including TMF and IRB files
Recommendation and documentation of CAPA plans to site, sponsor IRB’s and CRO’s
Quality assurance audits, Medical surveillance reporting, CIOMS, Risk assessments
GCP-ICH E-7 Clinical Quality Assurance auditing (more than 100) on-site field audits
Team building, negotiations, and decision influence training related to specific projects
CLIENTS:
BIOTEST PHARMACEUTICAL COMPANY Boca Raton, FL – Associate Project Manager Civacir Hepatitis C program
BRAIN MATTERS RESEARCH Delray Beach, FL – Compliance Officer, Regulatory and administrative duties, SOP’s, Auditing
CORNERSTONE PHARMACEUTICALS INC. Cranbury, NJ – Home Based Sr. CRA monitoring phase I/II Pancreatic cancer study
S. Maurer CV
PTC THERAPEUTICS, INC. South Plainfield, NJ – Home Based Sr. CRA monitoring phase I/II solid tumors with oral PTC299
ORTHOCON, INC. Newark, NJ – Consultant hemostasis implant device pain studies, monitoring management duties and SOP
writing
CARDIUM THERAPEUTICS, INC. San Diego, CA – Home Based Field Monitor Cardiovascular phase 2 BSL2 gene therapy AWARE
Study and TRC gene therapy diabetic foot ulcer MATRIX study monitor
EISAI MEDICAL RESEARCH, INC. Ridgefield Park, NJ – Home-based Field Monitor Breast Cancer phase 2
CEPHALON INC., Frazer, PA – Phase 1 Field Auditor
SEATTLE GENETICS, INC. Bothell, WA – Field Monitor phases 1 & 2 – HD, lymphoma, leukemia studies
ASTHMATX INC., Mountain View, CA – Home-based regional monitor phase 2 - Asthma device study (bronchial thermoplasty)
THERADEX SYSTEMS INC., Princeton Junction, NJ – Regional CRA phases 1, 2 & 3, monitoring pancreatic, solid tumor,
melanoma cancers
DOV PHARMACEUTICAL, INC. Hackensack, NJ – In-house Sr. CRA Consultant and home based regional monitor – records
auditor, CNS analgesics phase 2
BOEHRINGER-INGELHEIM PHARMACEUTICALS Ridgefield, CT – Home based regulatory document reviewer – Field CRA site
selection cardiovascular
SHIRE PHARMACEUTICALS, Rockville, Maryland - ARIS Local phase 1 monitor – hypertension/ADHD
BIOPURE CORPORATION, Cambridge, MA - In-house CRA Consultant - BLA HEMOPURE support activities, auditing, report
writing
MONITORFORHIRE.COM, Lower Gwynedd, PA - PRA Field Monitor Sepracor SAR/PAR Asthma study Phase 3
AVENTIS PHARMACEUTICALS, Bridgewater, NJ - Dante-Resources In-house CRA/RA medical writing/reviewing (anti-infective)
NDA/MAA submission of KETOLIDE
FOCUS MANAGED RESEARCH, Marlton, NJ - On-site Monitor/Manager/Trainer/CRA Consultant –
various projects phases 2,3 & 4 cardiovascular, CNS allergy Phases 3-4
Local Research Manager for
ALFACELL CORPORATION, Bloomfield, NJ - CRA support - phases 1-3 site monitoring responsibilities Pancreatic Cancer &
Mesothelioma ONCONASE
WARNER LAMBERT PARKE-DAVIS, Morris Plains, NJ - CRA monitoring support – Cardiovascular phase 4 ACCUPRIL
FOREST LABORATORIES, INC., NYC, NY - On-site medical writing, QA, and regulatory writing responsibility for PHYSOSTIGMINE
& CITALOPRAM NDA’s
PARAGON BIOMEDICAL, INC., Irvine, California Contract Device Monitor - phase 3 Nir-Vana Stent Program
COPLEY PHARMACEUTICALS, INC., Canton, MA - medical surveillance and writing duties for ALBUTEROL recall
DIRECT PATIENT CARE EMPLOYMENT:
2012 - 2013 TOWNE NURSING SERVICES, Lakewood, New Jersey
On Call CNA/HHA work at various Long Term Rehabilitation Facilities - Night Shift coverage
S. Maurer CV
INDUSTRY W-2 EMPLOYMENT:
2013 - 2013 SCRI DEVELOPMENT INNOVATIONS, Nashville, Tennessee
Home-Based Senior Clinical Research Associate Oncology Phase 1/2 (80% travel)
Lymphoma and Renal Cell Carcinoma early stage development site responsibility
2011 - 2011 RPS/ALLERGAN, Irvine, California
Senior Clinical Research Associate phases 2-3 (75% travel)
Home Based CRA and Un-Blinded international monitor
Botox product Overactive Bladder and Ophthalmology Darpin based diabetic macro-degeneration
1995 - 1996 OXFORD RESEARCH INTERNATIONAL CORPORATION, Clifton, New Jersey
Senior Clinical Research Associate /QA Auditor phases 1-4 (75% travel)
26 site monitoring responsibility, Aids - GANCYCLOVIR, Diabetes - CT112,
Hypertension - VALSARTAN, Abortion - MIFEPRISTONE, CRA training, pre FDA audit
1990 - 1993 FUJISAWA PHARMACEUTICAL COMPANY, Deerfield, Illinois
Senior Clinical Research Associate phases 1-3B (60% travel)
Managed 62 sites, 2 CRO's, supervised and trained 3 CRA's
GALLIUM NITRATE NDA, pre-approval auditing FK506, PROGRAF
1989 - 1990 SANDOZ PHARMACEUTICALS, INC., East Hanover, New Jersey
Senior Clinical Research Associate phases 1-4 (50% travel)
Co-managed Rx-OTC switch RANITIDINE Program
Designed studies, protocols, CRF's, assisted in writing ISS, IDB, Risk Assessment
1988 - 1989 PAREXEL INTERNATIONAL CORPORATION, Cambridge, Massachusetts
Clinical Research Associate phases 1-3B (75% travel)
Recruited and monitored 19 Aids and Cancer sites pivotal trials for
r-EPO and AEROSOLIZED PENTAMIDINE Approvals
1984 - 1988 NORWICH EATON PHARMACEUTICALS, INC., Norwich, New York
CRA - Phase 1 monitoring and bench lab analysis BA/PK studies: Phase 1-4 Site monitoring for Bacterial
Infections, Hypercalcemia, Multiple Myeloma, Breast Cancer bone pain studies, NDA DIDRONEL IV
MILITARY:
1979 - 1989 U.S. NAVAL RESERVE FORCES RNMCB-21, EPMU-6, BETH-902
Hospital Corpsman - Petty Officer Second Class
Reserve participation continued in various capacities and units involving hands-on patient care, training,
and supervision. Honorably Discharged.
1975 - 1979 U.S. NAVAL REGIONAL MEDICAL CLINIC, Pearl Harbor, Hawaii
Hospital Corpsman - Petty Officer Third Class
Extensive on-the-job training: Emergency Room, Sick Call, EKG, Pediatrics, X-Ray, Laboratory, Pharmacy,
Diagnosis & Treatment, leading to independent medical service responsibility for 300 military and 300 civil
service employees.
EDUCATION:
LTC MEDICENTER TRAINING
Neptune, New Jersey – May 2012 CNA, HHA, EKG CERTIFICATION
Master of Arts in Teaching, Monmouth University (22/32 credits completed - currently on leave of
absence) 1996 - West Long Branch, New Jersey
Bachelor of Science in Biology, Monmouth College, December 1983
West Long Branch, New Jersey
Associate in Arts Ocean County College, May 1981
Toms River, New Jersey
Hospital Corpsman, Naval School of Health Sciences, February 1976
Balboa Hospital, San Diego, California
College Preparatory Diploma, Lakewood High School, June 1975
S. Maurer CV
EDC /COMPUTER SKILLS:
MS Office Products, (Word, Excel, Power Point), CRF design, Data entry and coding, ICD-9/WHO/ART,
Databases - Lotus, SAS, Paradox, Access, Graphics - PageMaker, CorelDraw, Publisher, Visio and HTML,
CTMS, Proprietary EDC software experience - Documentum, Datatrack, ClickFind, ERT, Phase Forward,
InForm, FUSE, Medidata RAVE, Trial Master.
PROFESSIONAL ORGANIZATIONS:
American Medical Writers Association - member
Association of Clinical Research Professionals - member
Drug Information Association - member
Medical Reserve Corps MRC-CERT Manalapan, NJ – CERT EMT
Monmouth County Health Department MRC - EMT leadership team member
Society of Clinical Research Associates - member
CERTIFICATIONS/LICENSES:
Certified Medical Assistant - R7Y3G7J7 - NHA
Emergency Medical Technician – 511185 -NJ
EKG Technician - Z7B5Q5S5 - NHA
Phlebotomy Technician - E7W3X3Z8 - NHA
Patient Care Technician - P9H2L6H3 - NHA
Certified Nursing Assistant CNA - NA200007437 - NJ
Certified Home Health Aide CHHA - 26NH14026100 - NJ
VOLUNTEER WORK:
2015
2014
2012
2010
2009
1998
1990
–
–
–
–
–
–
–
Present
Present
2014
2014
Present
Present
Present
Delray Beach Chamber of Commerce – festival volunteer
Community Emergency Response Team - Delray Beach Fire and Rescue
PRN Parker Family Health Center – Free clinic providing patient care as Medical Assistant/LPN
Monmouth County Health Department MRC – EMT, leadership and training role
Manalapan Medical Reserve Corps / Community Emergency Response Team – member
Annual Falcon Ridge Folk Festival, Hillsdale NY – EMT/ Medical services
Annual Philadelphia Folk Festival Schwenksville, PA – EMT/ Medical services
PERSONAL:
Hot-Air Balloon Pilot, Certified Advanced Scuba Diver, Open Water Sailing Certificate, Camping,
Performance Arts, Music and Travel