S. Maurer CV

Scott W. Maurer

/ 14565 Candy Way Delray Beach, Florida 33484 (561) 372-8497 cell:(561) 862-8245
Email:
Website:

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 / CMV, KS, PCP / Biologic/Pharmaceutical / CRO / 3yrs
Anti-Infective / Phases 11-1V / UTI, URI, topical wounds / Biologic/Pharmaceutical / Pharma/CRO / 2yrs
Cardiovascular / Phases1-1V / HTN, Stroke, MI / Biologic/Pharmaceutical / Pharma/CRO / 5yrs
CNS / Phases 1-1V / ALZ, Depression / Pharmaceutical / CRO / 3yrs
Devices / IDE/510K
510K / Asthma, Hemostasis/pain
Cardiac Stent / Medical Device
Medical Device / Device Co.
CRO / 2yrs
1yr
GI / Phases 1-111 / GERD, surgical pain / Pharmaceutical/OTC / Pharma / 2yrs
Infectious Dis / Phase111-1V / SARS, HEP -C / Pharmaceutical / Pharma / 3yrs
Oncology / Phases 1-1V
Phases 1-111
Phases 1-1V / MM, Leukemia, HCal, Lymphoma, Melanoma
Solid Tumors, Lung, PC / Biologic/Pharmaceutical
Biologic/Pharmaceutical
Biologic/Pharmaceutical / Pharma/CRO
Pharma/CRO
Pharma/CRO / 6yrs
2yrs
5yrs
Ophthalmology / Phases 1-11
Phase II / Dry- eye, Retinitis,
Macular Degeneration / Pharmaceutical
Pharmaceutical / Pharma/CRO
Pharma/CRO / 1yr
2yrs
Respiratory / Phases1-111 / Allergy, Asthma / Pharmaceutical / Pharma/CRO / 2yrs
Pain / Phases1-111 / Bone, surgical / Pharmaceutical / Pharma/CRO / 3yrs
Reproductive / Phase 111 / Abortion / Pharmaceutical / CRO / 2yrs
Transplantation / Phase 111 / Kidney, Liver, Sm bowel / Pharmaceutical / Pharma / 2yrs

SKILL SETS

  • 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

PTC THERAPEUTICS, INC. South Plainfield, NJ– Home Based Sr. CRA monitoring phase I/II solid tumors with oral PTC299

ORTHOCON, INC. Newark, NJ – Consultanthemostasis 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 selectioncardiovascular

SHIRE PHARMACEUTICALS, Rockville, Maryland -ARISLocal 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 – Local Research Manager for various projects phases 2,3 & 4 cardiovascular, CNS allergy Phases 3-4

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

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 Carcinomaearly 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– May2012 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

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- EMTleadership 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 – PresentDelray Beach Chamber of Commerce – festival volunteer

2014 – Present Community Emergency Response Team - Delray Beach Fire and Rescue

2012 – 2014PRNParker Family Health Center – Free clinic providing patient care as Medical Assistant/LPN

2010 – 2014Monmouth County Health Department MRC – EMT, leadership and training role

2009 – Present Manalapan Medical Reserve Corps / Community Emergency Response Team – member

1998 – Present AnnualFalcon Ridge Folk Festival, Hillsdale NY – EMT/ Medical services

1990 – Present AnnualPhiladelphia 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