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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