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| Desired Industry: Biotech |
SpiderID: 18684 |
| Desired Job Location: Pittsburgh, Pennsylvania |
Date Posted: 1/30/2008 |
| Type of Position: Contractor |
Availability Date: 03/01/08 |
| Desired Wage: |
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U.S. Work Authorization: Yes |
| Job Level: Management (Manager, Director) |
Willing to Travel: Yes, 50-75% |
| Highest Degree Attained: Bachelors |
Willing to Relocate: Undecided |
Objective:
Home-Based Contract Clinical Research Postion - Sr/Management Level
Experience:
1997 Present
Clinical Research Consultant-Senior Level CRA/CRA Management/Regional PM
Senior level CRA/ Project/Site Management for pharmaceutical and device research studies sponsored by U.S. and internationally based pharmaceutical companies including: Breast Cancer International Research Group, Aventis (Paris), Globomax, ICON, Astra Zeneca, Novo Nordisk and MedImmune Oncology, Inc., Premier Research, GSK, Cephalon.
Primary Function:
Investigative Site Monitoring and Study Management
CRA Training/Mentoring/Staffing (max: to date-200 field nurses/coordinators/field monitors)
Training and maintaining staff on all aspects of the studies.
Extensive knowledge of ICH Guidelines
Study Coordinator and Study Staff Training as applicable.
Organizing and conducting study related meetings.
Newsletters.
Sponsor Audits - Study Site and Master Trial Files
Monitoring - Regulatory and Data Point
Investigator identification and site selection.
Contract negotiations
Budgets and Vendor Management
Regulatory document management and review (PM level)
Study materials development, management, and tracking including but not limited to: Protocol development and review, Informed consents, source documents, CRFs and newsletters. Study/Site Initiation and Closeout Visits
Primary focus:
Sponsor Initiated, Cooperative Group, and Physician Initiated Projects.
Sponsor Audits/Study rescue (transition studies back in-house to Sponsor from CRO)
Age groups include Adult, Pediatric, and Neonatal.
Monitoring Phases:
Phases 1- 4
Retrospective Data Collection.
Clinical Research Settings:
Academic, Private, Plasma Centers, and Institution.
Additional Experience:
Research Site Establish/Staff/Train/Manage Phase 1-3
Sites. (22 Phase 3/ 7 Phase 1)
Budgets/Contracts/Business Development Phase 1-3 sites
Physician recruitment/training/management Phase 1-3 sites
Physical Research Site location setup and development
Phase 1-2 NIH Research Manager
Remote data entry trials, CRF
Fax retrieval and submission.
Studies done in retrospect
Drug coding
Edit writing
AE coding
Edit revision
Therapeutic Areas Include:
Hematology/Oncology/BMT Certified Oncology Nurse
Leukemias/ Pediatric and Adult, Breast Cancer
(3 years with Breast Cancer International Research Group), Lung CA, Malignant Melanomas, Malignant Myeloma, Non-Hodgkins Lymphoma, Wilms Tumor, Antiemetics.
Autoimmune Diseases - AIDS (Adult and Pediatric), Shingles
Cardiology- Acute Coronary Syndrome, Congestive Heart Failure, Hypertension, Transplant
Endocrine / Metabolic (NIH/Physician Initiated Research Phase I IV) including but not limited to : Cushings, Cystic Fibrosis, Diabetes, CAH, Wilsons Disease, Pagets Disease, Hyper/Hypo Thyroidism) Phase I, II, III Device SR, Eating Disorders, GI Disorders, Dumping syndrome, Irritable Bowel Syndrome.
Vaccine - Neonate through Adult. (Staph Vaccine and HepVax)
Pulmonary- CA, Transplant (Liver/Lung), Cystic Fibrosis,
Womens Health-HRT, Breast Cancer, Endometriosis,
Fibrocystic Breast.
CNS Alzheimers (ADAS Rater) Epilepsy, Depression, Mood Disorders, Adult/Pediatric, ADD/ADHD
Orthopedic- OA/RA/Surgical Hip-Device, Chronic and Post Op Pain Management
Pain Management Acute, Chronic, Device
Pediatrics / Neonatal Allergy, Asthma, Transplant, Renal Disorders, Oncology, Vaccine, Endocrine, Metabolic.
Asthma and Allergy - Phase 1 - 3
Dental Device, Smoking Cessation
Dermatology- Shingles
1995 1997 DIRECTOR-CLINICAL RESEARCH
(SMO) Site Management Organization
ICSL Clinical Studies
Director of multi-discipline clinical research sites within the Eastern US.
Responsibilities included the management of all business acquisitions, personnel management for all divisions (250 Employees and Physicians)
Primary business contact for all sponsors, contract research organizations and medical consultants.
Responsible for supervision of all clinical activities for these sites.
1993 1995 PROJECT MANAGER/CRA MANAGER
Concept One Medical Research Consultants, Inc.
Miami, Florida
(CRO) Contract Research Organization
Study Investigator identification and selection.
Contract negotiations for internationally based sponsor.
Regulatory document retrieval, review and approvals.
Materials supply and investigational product control.
Study Management
Regional CRA Management.
1983 - 1989 CLINICAL RESEARCH UNIT MANAGER
NIH/CDC Operated Clinical Research Unit
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania
28 bed NIH/CDC governed, multi-discipline, Phase I IV Research unit.
Therapeutic areas included hematology, oncology, transplantation, (heart, liver, bone marrow) metabolic and endocrinology disorders.
Supervision and training of unit research nurses and coordinators in all aspects of clinical trial testing and management.
Chemotherapy and BMT Certified Oncology Nurse.
OTHER PROFESSIONAL EXPERIENCE:
1991 - 1993 DIRECTOR OF PEDIATRICS
American Complex Care, Inc.
Plantation, Florida
Established and implemented a pediatric home infusion program for pediatric oncology patients. Including policies and procedures, staff recruitment and training, program marketing and business development for this medical device and infusion company.
Certified Registered Nurse of Infusion
DIRECTOR OF NURSING AND BUSINESS DEVELOPMENT
American Complex Care, Inc.
Plantation, Florida
Director of Nursing for the Infusion Division, Medical Device Division, and Nursing Division.
Responsibilities included the management of all business acquisitions, personnel management for all divisions, physician marketing and contracts.
1989 - 1991 ASSISTANT HEAD NURSE
Miami Childrens Hospital, Miami, Florida
Hematology, Oncology, Bone Marrow Transplant Unit
Recruited from Pittsburgh Childrens Hospital to assist with staff educational needs and training for the care of pediatric bone marrow transplant patients.
Established hospital cancer support group for parents of children terminal illnesses.
Clinical Preceptor for Pediatric Nursing Program-University
of Miami.
Education:
Present
George Washington University
Washington, DC
Graduate Program Clinical Leadership Clinical Research Administration
1998 2001
George Washington University
Washington, DC
Bachelors Degree in Health Sciences
Clinical Research Administration
1983 - 1986
La Rouche College
Pittsburgh, Pennsylvania
Nursing
1981 - 1983
St. Francis General Hospital
Pittsburgh, Pennsylvania
Registered Nursing
1980 - 1981
University of Pittsburgh
Pittsburgh, Pennsylvania
General Studies
Affiliations:
ACRP
DIA
The National Collegiate Scholar
Society for Academic Excellence
The George Washington University
Golden Key Honors Society
Skills:
Proficient Computer Skills
Additional Information:
State of Florida & State of Pennsylvania Nursing Licensed
Certified Oncology/BMT Nurse
Certified Registered Nurse of Infusion
Certified Clinical Research Associate
Candidate Contact Information:
This candidate has chosen not to make contact information available on this page.
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