Clinical Research Management
Resume:
ROBERT KIRSHOFF, MS, CNS, CCRC
Melville, NY 11747
acs5lf@r.postjobfree.com
Career Summary
Clinical research professional with extensive leadership, project management, clinical development, and clinical operations experience in the pharma and CRO landscapes with prior experience in private and academic site management. Skilled in all clinical development and clinical operations tasks. A team player, skillful at forging collegial relations with senior management, other departments and KOLs. Experienced in all phases of clinical development. Knowledgeable and experienced in a multitude of therapeutic areas. Global experience. ACRP certified. Employment History
Noven Pharmaceuticals, New York, NY November 2009 - Present Associate Director of Clinical Research
2 successful NDAs
Met primary endpoints on over 10 clinical trials, phases 1 - 3
Select and manage CROs
Design, develop and author study protocols
Supervise direct reports
Write and update Investigator’s Brochures
Review, edit, and manage publication of CSRs
Review and edit ISS/ISEs
Represent sponsor at FDA meetings
Mentor and manage project managers
Manage study time lines, budgets, and contracts
Train site personnel at investigator meetings and SIVs
Develop study materials
Review study data (TLFs)
Organize and lead advisory boards with KOLs
Perform due diligence on new product opportunities Research Associates of New York, New York, NY February 2009 - October 2009 Clinical Operations Consultant
Created a 5-year business plan for site management business venture
Launched site management business
Supervised 4 direct reports
Ockham Development Group, Cary, NC June 2008 - February 2009 Executive Director of Clinical Operations
Project manager on 2 global oncology studies
Supervised 5 direct reports
Consulted on and refined protocols for clients
Represented the company at bid defenses
Found and developed new business opportunities
Generated RFP responses
Assessed site’s capabilities and made final site selections for multi-center trials
Performed PSSVs and SIVs.
Field monitoring as necessary
Winthrop University Hospital, Mineola, NY September 2005 - May 2008 Director of Clinical Trials
Supervised 12 direct reports
Secured AAHRPP accreditation for the institution.
Developed and implemented clinical trial SOPs, standardized for the institution.
Developed and implemented new quality improvement program.
Consistently increased gross revenue three successive years
Trained staff of over 100 physicians and study coordinators
Established solid relationships with numerous sponsors CONSULTANT 2005 – 2009
Trial Design and Clinical Operations Consultant, Natrogen Therapeutics (New York, NY)
Trial design and Clinical Operations Consultant, Eagle Pharmaceuticals, Inc. (Woodcliff Lake, New Jersey),
Trial Design Consultant, Data Driven Innovations (Westhampton, New York),
Scientific (IBD) Consultant, Ockham Development Group Inc. (Cary, North Carolina)
Site Management Consultant, MMG/National Institute for Drug Abuse (Rockville/Baltimore, Maryland)
Protocol and Trial Design Consultant, EMET Pharmaceuticals, LLP (Great Neck, New York) Long Island Clinical Research Associates, Great Neck, NY September 2001-August 2005 Director of Clinical Research
Supervised 6 direct reports
Established a consistently top-enrolling site
Increased yearly gross revenue by $1M
Intecardia (Chapel Hill, North Carolina; Massapequa, New York) September 1999-August 2001 Site manager
Arena Oncology 1999-2001
Nutrition Consultant
St. Luke’s Roosevelt Hospital Colon Polyp and Cancer 1994-1999 Prevention Center (New York, New York)
Research Nutritionist/Study Coordinator
Managed 2 NCI-funded studies on chemo-prevention of colon cancer Professional Guitarist 1985-1999
Music Industry
Guitarist for Radio City Orchestra
Guitarist for numerous Broadway Shows (Evita, Joseph and the Amazing Technicolor Dreamcoat, Blood Brothers, etc.)
Guitarist on numerous jingles and recordings
Jazz performances with Gerry Mulligan, Zoot Sims
Performances with Liza Minelli, Carole King, etc. Education
Master of Science in Nutrition (Magna Cum Laude), Hunter College of the City University of New York, 1996
Bachelor of Arts in Music, Hunter College of the City University of New York, 1991 THERAPEUTIC EXPERIENCE
Gastro-Intestinal: Ulcerative Colitis, Cohn’s Disease, GERD, FD
Psychiatric: ADHD
Oncology: Colon, Breast, Prostate, GBM
ID: Onychomycosis, Nosocomial Infection, HAI
Orthopedics: Post-Op VTE, Tibial Fracture
Women’s Health: VMS
CNS: MS, AD, Epilepsy, Stroke, PD
Cardiovascular: CAD, CHF, Device
Rheumatology: RA, OA, Gout
Endocrinology: Diabetes, Osteoporosis, Thyroid Disorders
Allergy and Immunology: HAE, Seasonal Allergies
Internal Medicine: HTN, Obesity, Insomnia
Anesthesia: Post-Op Nausea, Post-Op Pain
Pediatrics: ID, Vaccine, Infant Formula
Pulmonology: COPD, VAP, Bronchiectasis, PSG
CONTINUING EDUCATION AND TRAINING
Leadership training, Noven 2015
Clinical Trial Project Management Certificate, Halloran, 2011
Public Responsibility in Medicine and Research, Association for the Accreditation of Human Research, 2007
Certificate, Management Development, Hofstra University, Uniondale, NY, 2007
Developing Clinical Trial Budgets, Barnett International, 2002
Good Clinical Practice, Columbia Presbyterian Medical Center, 1997 PROFESSIONAL MEMBERSHIPS AND ORGANIZATIONS
Member, Association of Clinical Research Professionals (ACRP), 2004
Member, Drug Information Association (DIA), 2004
Member, American Federation of Musicians, 1980
CERTIFICATION AND ACCREDITATION
Protection of Human Research Subjects, Collaborative IRB Training Initiative, 2006
Certified Clinical Research Coordinator (CCRC), Association of Clinical Research Professionals
(ACRP), 2004, re-certified 2008, 2012, 2014
Certified Nutrition Specialist (CNS), America College of Nutrition, 1997 HONORS AND AWARDS
Noven Platinum Award for Outstanding Contribution to the timely submission of the Minidot NDA, 2012
James Felt Research Scholarship in Health Sciences, Hunter College of the City University of New York, 1996
PUBLICATIONS AND PRESENTATIONS
Presentations
Noven Pharmaceuticals, ADHD program study results to advisory board, 2015
Noven Pharmaceuticals, Investigator meeting, Central ad campaign presentation to sites, 2011
Noven Pharmaceuticals, Pharmacodynamic study results to advisory board, 2011
Eagle Pharmaceuticals, Investigator Meeting Protocol Presentation to South African Investigators, Johannesburg, South Africa, 2009
Eagle Pharmaceuticals, Investigator Meeting Protocol Presentation to Eastern European Investigators, Hyatt Regency Hotel (Istanbul, Turkey), 2008
EMET Pharmaceuticals, Investigator Meeting Multi-Center Clinical Trial Protocol Presentation to Ukrainian Sites, Divan Hotel (Istanbul, Turkey), 2007
Consenting: Facts and Pitfalls of the Informed Consent Process, Winthrop University Hospital IRB Monthly Lecture Series, 2007
Current Trends in Gastro-Intestinal Clinical Research, Winthrop University Hospital G.I. Residency Program Grand Rounds, 2006
Clinical Research Diabetes and Nutrition, Winthrop University Hospital Community Outreach Center, 2006
Current Trends in Gastro-Intestinal Clinical Trials, Winthrop University Hospital G.I. Residency Program Grand Rounds, 2005
Publications
Curcumin Therapy in Inflammatory Bowel Disease: A Pilot Study, Digestive Disease and Sciences, Vol. XX. No. X (XXX 2005), pp. 1-3, Peter R. Holt, MD, Seymour Katz, MD, Robert Kirshoff, MS, 2005
Nutrition and the Musician, Allegro, Vol. CI No.5 May, 2001 Medical Writing
A Randomized, Single Dose, Three-Way Crossover Study To Determine the Effects of a Non- Occlusive Overlay and First Aid Tape on the Pharmacokinetics of XXXXXXX in Healthy Adult Subjects, 2014
A Phase III, 5-Week, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo- Controlled, Fixed Dose with Titration, Safety and Efficacy Study of XXXXXXX in Subjects with XXXXXXX, 2013
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Laboratory Classroom Study to Evaluate the Safety and Efficacy of XXXXXX Compared to Placebo in Children and Adolescents with ADHD, 2012
A Phase 1, Open-Label, Single-dose, Randomized, 2-Way Crossover Study to Demonstrate Bioequivalence between XXXXXX and XXXXXX in Healthy Subjects, 2012
A phase I Single-Dose, Open-Label, Three-Way, Randomized, Crossover Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of XXXXXXX in Children with ADHD, 2010
A Phase I, Single Center, Single Dose, Open-Label, Randomized, Crossover Study to Demonstrate Bioequivalence of XXXXXXX versus XXXXXXX in Healthy Postmenopausal Women, 2010
A Phase IIA, Open-Label, Multiple Dose, One-Way Cross-Over, Analog Classroom Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XXXXXX, Compared to XXXXXXXX, in Children with ADHD. 2010
Efficacy and Tolerability Study of XXXXXX in the Treatment of Patients with Active Ulcerative Colitis. 2009
A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Dose-Finding Study of the Safety and Efficacy of XXXXXXX in Patients with Closed Fractures of the Tibial Diaphysis 2008
A Double-Blind, Placebo-Controlled, Parallel-Design, Three-Arm Bioequivalence Study with Clinical Endpoints Comparing XXXXX, to the Reference Listed Drug XXXXXX in Patients with Ulcerative Colitis. 2007
A Double-Blind, Placebo-Controlled, Parallel-Design, Three-Arm Bioequivalence Study with Clinical Endpoints Comparing XXXXXX, to the Reference Listed Drug XXXXXXX in Patients with Ulcerative Colitis. 2006
A Pilot Study of Efficacy and Safety of Curcumin in Crohn’s Disease. 2003
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