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Clinical Research Associate Resume
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| Desired Industry: Biotech |
SpiderID: 26269 |
| Desired Job Location: Montréal, Québec |
Date Posted: 4/22/2009 |
| Type of Position: Contractor |
Availability Date: 01May09 |
| Desired Wage: 95000 |
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U.S. Work Authorization: Other |
| Job Level: Experienced with over 2 years experience |
Willing to Travel: Yes, 50-75% |
| Highest Degree Attained: High School/Equivalent |
Willing to Relocate: No |
Objective:
Obtain contract position with a pharmaceutical/biotech company.
Experience:
Seventeen Studies conducted in the following Therapeutic Areas:
- Neurology: Epilepsy, Multiple Sclerosis
- Musculoskeletal: Rheumatoid Arthritis, Osteoporosis
- Genitourinary: Erectile Dysfunction and Type II Diabetes
- Nephrology: Chronic Renal Failure
- Immunology: Influenza, Recurrent Respiratory Papillomatosis
Education:
Laurentian University - Bachelor of Arts - Psychology - 1995
Humber College - Clinical Research Program
Affiliations:
Will be applying for ACRP accreditaton in June 2009 for September 2009 session.
Skills:
Bilingual French and English
Excel with computer software.
EDC experience
Additional Information:
• Monitored all stages, from evaluation to close-out, of the conduct of clinical trials at assigned trial sites, wrote reports, maintained required documentation in the investigator file and provided required documentation for the Trial Master File, while adhering to protocols, Standard Operating Procedures, ICH GCP and local requirements.
• Technical Lead CRA for monitoring visit report software and miscellaneous computer related team requirements.
• Responsible for training new team members for Novartis extension study; including but not limited to protocol, CRFs and CRF guidelines, …)
• Facilitated negotiating grants and contracts, and budget forecasting and payments.
• Coordinated and generated clinical payments according to clinical research agreements.
• Collected and reviewed essential regulatory documents.
• Created monitoring tools/aids for team members.
• Created source document templates and study tools/aids for site usage.
• Reviewed master, country and site specific ICFs including minor translations.
• Reviewed colleague’s monitoring visit reports when requested by Project Manager.
• Responsible for recruiting potential investigators.
• Presenter at Investigator Meeting.
• Generated, edited and formatted a quarterly newsletter.
Reference:
Available upon request.
Candidate Contact Information:
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