Objective:
 

I desire a position with a dynamic company.


Work Desired:College Internship
Citizenship:US Citizen
Resident Of:State: Pennsylvania - Area Code: 215
Willing To Relocate:No
Posted By Candidate:01/04/10
Experience:More than 3 years of work-experience
Technical Skills:, LAN/Networking, Project Management
Work Experience:

Chicago, IL 60610
Philadelphia, PA 19123
312.375.7806

Please Note: Dual Residences (Chicago, IL and Philadelphia, PA)

EDUCATION / QUALIFICATIONS

Roberts Wesleyan College: Rochester, NY
BA

Licensed Practical Nurse, NY - expires 09/2011

PROFESSIONAL EXPERIENCE

Contract CRA - February 2005 - present
Regional/home Based
 * Senior Study Monitor - Phase III CVA/Acute Stroke trial (Medical Device)
 * Senior Study Monitor - Phase III Interventional Cardiology/Stent trial
(Medical Device)
 * Senior Study Monitor - Phase III Dual Anti-Platelet Therapy S/P Percutaneous
Intervention Trial (Compound)
 * Senior Study Monitor - Phase III Hemodialysis trial (Compound)
 * Senior Study Monitor - Phase II/III pediatric pain trial (Medical Device)
 * Senior Study Monitor - Phase III CHF trial (Medical Device and Compound)
 * Senior Study Monitor - Phase III Epilepsy trial (Medical Device)
 * Senior Study Monitor - Phase II/III Adult Pain trials (Compound)
 * Senior Study Monitor - Phase III Pediatric Pain trials (Compound)
 * Senior Study Monitor - Phase II/III Schizophrenia/Bi-Polar trials (Compound)
 * Senior Study Monitor - Phase II/III Oncology Pain trials (Compound)
 * Senior Study Monitor - Phase III Dermatology trials -(Squamous/Basal Cell
Carcinoma) - (Compound)
 * Responsible for study-related activities within assigned sites in Midwest and
throughout the USA (start-up, initiation, interim monitoring, and close-out
visits)
 * Ensured that site study conduct is in compliance with SOPs, GCP/ICH
guidelines and adherence to protocol
 * Actively involved in recruitment strategies (communication is key to
recruitment deadlines being met)

Medifacts International
Regional/home-based
Project Manager/Clinical Study Manager - February 2003 - January 2005
 * Phase III CHF trial
 * 55 sites in North America (USA and Canada)
 * Directly responsible for all project related timelines
 * Microsoft Project proficient
 * Direct line manager for 10 regional CRAs (trip report/expense report review
and approval, time management, etc) - involved in direct
hiring/training/mentoring of all project team members
 * Manage vendors and Investigational Product inventory
 * Responsible for contracts (site and vendor), project budget, billing
trackers/reconciliation. (Vendor and Investigator payments)
 * Project Manager with this trial from pre-study to close-out
 * Exceeded recruitment expectations - (enrollment completed 6 weeks early)
 * Conducted/organized two regional training sessions for project team

Lead Clinical Research Associate - February 2002 - January 2003
 * Phase III Hyponatremia trial
 * Phase III CHF trial
 * Phase III CV Device trial
 * Phase III Cardiac Catheterization trial
 * Phase II Oral Heparin trial
 * Mentor for new/transitional Clinical Research Associates
 * Presenter at Investigator Meeting for CHF, Osteoarthritis/Insomnia, and
Hyponatremia trials
 * Evaluation/Selection/training of site personnel
 * Study site budget/contract negotiations and payments
 * Protocol development/writing/edit (multiple trials phase II-IV)
 * Writing clinical reports and NDA submission
 * CRF development (multiple trials Phase I-IV)
 * Proficient in RDC/EDC

CroMedica Inc
Regional/home-based
Clinical Research Associate II - July 2001 - January 2002
Clinical Research Associate - June 2000 - June 2001
 * Phase IV Parkinson's Disease Trial
 * Phase I Parkinson's Disease Trial
 * Phase I Type I Diabetes Trial
 * Assisting with the Development of Case Report Forms and Source
 Documentation for Type I Diabetes Trial
 * Presenter at Investigator Meeting - Type I Diabetes Trial

The Diabetes/Endocrinology Center of Western New York - Kaleida Health 
Clinical Research Coordinator - August 1997 - July 2000
 * 10 Diabetes Clinical Trials (Types I & II)
 * 5 Complications of Diabetes Clinical Trials (Nephropathy & Neuropathy).
 * 4 Endocrinology Clinical Trials (Hypopituitary, Acromegaly & Obesity)
 * Congestive Heart Failure and Hypertension Clinical Trials
 * Recruitment and retention using creative/innovative techniques
 * Advertising within the various media
 * Data entry
 * Maintaining up to date CRF entries and source documentation for multiple
Clinical trials
 * Venipuncture and the processing of labs
 * Actively involved in all aspects of Phase I/II-IV Clinical Trials and various
specialized procedures associated with each trial
 * Working knowledge of GCP's and regulatory compliance issues
 * Improved operational performance procedures at the center for data query
response and management

American Red Cross
Apheresis Collections Specialist II - October 1996 - July 1997

Erie County Medical Center Staff Nurse Trauma Intensive Care Unit - July 1989 -
September 1996
 * Responsible for all aspects of care for acutely ill trauma patients
 * Working knowledge of all aspects of hemodynamic monitoring
 * Clinical Research Assistant for Methylprednisone Clinical Trial (Spinal cord
Injury)

Continental Airlines
Flight Service Manager - March 1987 - June 1989
 * Responsible for staff, passengers, schedule and delays for all assigned
flights

Hermann Hospital
Staff Nurse Surgical Intensive Care Unit & Emergency Department
January 1984 - February 1987
 * Responsible for all aspects of care for acutely ill patients in a Level 1
Trauma Center

Wyoming County Community Hospital
Staff Nurse Medical/Surgical Intensive Care Unit & Emergency Department
May 1981 - December 1983

PROFESSIONAL MEMBERSHIPS

 * American Diabetes Association (ADA)
 * Drug Information Association (DIA)
 * New York State Nurses Association (NYSNA)
 * Association of Clinical Research Professionals (ACRP)

 

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