CURRICULUM VITAE
George E. Skemp
CURRENT ADDRESS:
Fountain Hills, AZ 85268
Telephone: 480-***-****
Fax: 480-***-****
E-mail: ******.*****@*********.***
EDUCATION:
Graduate: THE UNIVERSITY OF NEW MEXICO
Albuquerque, New Mexico
Degree: Master of Science (M.S.)
Major: Physical Education / Sports Business & Administration
Grad. Date: May 1992
Undergraduate: THE UNIVERSITY OF NEW MEXICO
Albuquerque, New Mexico
Degree: Bachelor of Arts (B.A.)
Major: Criminal Justice
Grad. Date: December 1989
WORK EXPERIENCE:
Employer: ANALYTIKS CLINICAL RESEARCH SERVICES, INC.
Position: Independent Senior Regional Clinical Research Associate / Consultant / Co-owner
August 2010 – Present
Date:
Experience: THERAPY PHASE DISEASE STATE SPONSOR
Oncology Phase I Solid Tumor Pathway (Novella)
Gastroenterology Phase III CV / Gastric Ulcer Pozen (Novella)
Respiratory Phase III Asthma TEVA (Novella)
Pulmonary Phase II Idiopathic Fibrosis BMS (Duke)
Employer: MERCK LABS (previously Schering-Plough Research Institute)
Position: Senior Regional Clinical Research Associate
North American Clinical Trials Organization (NACTO)
January 2005 – August 2010
Date:
Experience: THERAPY PHASE DISEASE STATE
Allergy/Immunology Phases II, III, & IV Rhinitis, Asthma, COPD, Nasal Polyps
& Respiratory
Cardiovascular Phases II & III Hyperlipidemia, Obesity
Hepatology Phase III Hepatitis C
Parkinson’s Disease
CNS Phase II
Crohn’s Disease
Immunology Phase I
Oncology Phase II Osteosarcoma
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Responsibilities: Coordinate and manage the activities associated with the conduct of domestic and
international Phase I, II, III and IV, pediatric and adult clinical studies. These activities
include but are not limited to: conducting site identification/selection/evaluation,
interim site monitoring and site closeout, regulatory document collection/review,
informed consent review, protocol compliance oversight, adverse event reporting,
accurate/complete data collection and discrepancy management. Also assure adherence
to FDA regulations and ICH guidelines (GCPs) as well as company Standard Operating
Procedures (SOPs). Assist with computer application training (i.e. expense reporting,
EDC and SPRI administration applications) as well as new-hire mentoring.
Duties Include: 60 to 70% travel to conduct pre-study, initiation, interim and close-out site visits as well
as investigator study meetings, regional CRA meetings and annual NACTO meetings.
Completion of regular compliance/SOP training and typical CRA administrative duties
Employer: SCHERING-PLOUGH, INC.
Position: Field CRA Training (Internship)
May 2003 – December 2004
Date:
Responsibilities: Observation, instruction and application in clinical research monitoring.
Duties Included: Part-time co-monitoring: Accompanied regional CRAs to pre-study, initiation and
interim site visits for Phase III hyperlipidemia studies; examined source documents,
regulatory documents, case report forms (paper & electronic) and data queries;
underwent specific instruction in Schering-Plough computer applications which
included Protocol Site Information Tracking (PROSIT) and electronic data capture
(InForm); reviewed Standard Operating Procedures (SOPs), FDA regulations and ICH
guidelines.
Employer: SCHERING-PLOUGH, INC.
Position: Field Sales Representative / District Computer Coordinator
July 1999 – January 2005
Date:
Responsibilities: Maximize sales and growth of market share in promoted cardiovascular, allergy /
respiratory and dermatology products through prioritized sales presentations to targeted
health professionals.
Duties Included: Development/implementation of business action plan; analyze sales data and physician
prescribing habits to maximize productivity; continually develop strategies to optimize
all business opportunities; identify and develop new business opportunities within
territory; coordinate action plan(s) with field counterparts; maintain awareness of
industry trends, clinical developments and product knowledge; adhere to strict FDA and
company guidelines regarding sample accountability and fraud and abuse compliance
issues; periodic recruitment of post-marketing study sites; perform and comply with all
administrative duties in a timely and accurate manner; management of weekly travel
and entertainment budget; conduct initial computer training for new-hires; act as liaison
between district members and computer call center; and quarterly publication of district
newsletter.
Employer: ARIZONA CARDINALS (NFL)
Position: Corporate Sales / Game Day Operations
Date: May 1996 - June 1999
Responsibilities: Season/group ticket sales and corporate sponsorship sales prior to and during NFL
season; game-day operational duties (promotions, game services, field
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operations/security etc.); promotional/special event set-up and operation; customer
service inquiries and miscellaneous office duties.
Owner: SOUTHWEST SPORTS VENTURES
Date: November 1994 - April 1997
Position: Owner
Responsibilities: Southwest Sports Ventures (SSV) published a newsletter (10,000 - 15,000 monthly
circulation) for five (5) Phoenix area LA Fitness Sports Clubs. Revenue from the
newsletter was generated through advertising sales. SSV also created, promoted, and
administered all sports activities, clinics, and group excursions for club members (i.e.
basketball, volleyball, and racquetball leagues/tournaments, swimming programs,
fitness cruises, etc.).
Employer: MAJOR LEAGUE BASEBALL - THE ARIZONA FALL LEAGUE
Position: General Manager - 1995 Fall League Champion Mesa Saguaros
Date: June 1995 - December 1995 (Seasonal Position)
Responsibilities: Corporate sponsorship sales; marketing, promotion, and operational/administrative
management for one (1) of six (6) teams in MLB's Arizona Fall League; admini strative
management of stadium and game-day staff.
Duties included: Acquisition of seasonal corporate sponsors (i.e. league/team sponsors, program
advertisers, etc.); off-field management of players (i.e. housing/banking needs, travel
arrangements, etc.); administration and direction of game-day staffing requirements,
payroll, game-day gate (tickets) and novelty/program receipts, field and stadium
maintenance and care, clubhouse operations, public relations, coaching staff requests,
media relations/requests, etc.
Employer: LA FITNESS SPORTS CLUBS - ARIZONA, INC.
Position: Director of Operations
Date: April 1993 - November 1994
Responsibilities: Overall management of club operations (4 clubs)
Duties included: Direction and supervision of member service, maintenance and custodial staff;
accounting of daily "gross" receipts; upkeep of personnel files; administration of
payroll; design and implementation of inventory control systems, maintenance record
systems, and work/purchase order systems; purchasing of equipment and supplies;
establishment of service contracts with local vendors (i.e. pool service, air conditioning
service, equipment maintenance, printing, etc.); assistance in the "set-up" of pre-sale
locations at future club sights; development, marketing, and promotion of all sports and
leisure activities and various administrative duties.
Employer: THE COLLEGE OF SANTA FE
Position: Assistant Department Director of Intramural/Club Sports, Outdoor Recreation, and of
Facilities
Date: September 1992 - April 1993
Responsibilities: Created, promoted and administered intramural sports, club sports and outdoor
recreation programs for the campus community at the College of Santa Fe's Driscoll
Fitness Center.
Duties included: Direction and supervision of student staff; purchasing of supplies and equipment;
scheduling, promoting, staging and supervision of intramural and other athletic events;
organizing, promoting and supervising outdoor recreation events; teaching basic
instruction courses in P.E.; development of Summer Camp Program for Santa Fe area
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youths; assisting the Director of Recreation in complete management of Fitness Center;
other administrative duties.
COMMITTEES/SOCIETIES/PROFESSIONAL AFFILIATIONS:
- Drug Information Services (DIA) Member
- Association of Clinical Research Professionals (ACRP) Member
RELEVANT TRAINING:
- DIA Training Course - Fundamentals of Clinical Research Monitoring April 2004
- Nat’l Jewish Medical/Research Ctr. - Allergy/Respiratory Preceptorship March 2000
COMPUTER SKILLS:
- Proficient in multiple computer applications including Microsoft Office software.
- Extensive experience in desk-top publishing, spreadsheets and word processing.
- Extensive experience with electronic data capture (InForm, BioClinica, MediData), Electronic Expense
Reporting, and CTMS Systems (Oracle, PROSIT).
SPECIAL COMMITTEES (Schering-Plough / Merck):
- NACTO Website Development Team, NACTO National Meeting Planning Team, New Hire Development
Team, MSL/CRA Task Force, Territory Development, CRA Mentoring.
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