999 Main Street, Any Town, New York 99999
Phone: (999) 999-9999 Cell: (999) 999-9999
Email: email@gmail.com
Thomas White
Objective:
To be responsible for the administration, initiation and monitoring of clinical research projects in accordance with FDA regulations and ICH-GCP Guidelines.
Work experience:
ABC Inc. Any Town, NY
Clinical Research Associate September 2008 – Present
- Identifies potential investigator sites.
- Performs comprehensive site management activities.
- Provides consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and FDA, ICH GCP guidelines.
- Helps to define quality standards within the project team.
- Conducts Pre-Study Monitoring visits. Reviews study plans with clinical investigators and evaluates clinical sites to ensure that they meet all study parameters and all FDA and GCP guidelines.
- Conducts Site Initiation visits. Reviews and explains study protocols with clinical investigators and clinical site staff.
- Serves as consultant to site personnel on all sponsor-related SOPs and regulatory requirements.
- Conducts Interim Monitoring visits. Reviews source documents, CRFs, regulatory documents, Informed Consents,
- Investigation Product, and clinical supply accountability.
- Ensures all Adverse Events have been documented and reported according to FDA regulations and sponsor protocols.
- Provides feedback and training to site personnel as needed.
- Conducts Close-Out visits. Retrieves and reconciles all study supplies.
- Archives study documentation and prepare the clinical site for any potential audits.
- Produces timely and comprehensive visit and status reports with minimal corrections and rewrites.
- Within International – collection of high quality critical documents and completion of ethics committee and regulatory submissions as applicable.
- Completes all other assignments given by management or as business needs require.
XYZ Corp. Any Town, NY
Associate Research Coordinator April 2008 – September 2008
- Dietary Intervention Study in Children.
- Trials of Hypertension Prevention.
- Women’s Health Initiative.
BCD Inc. Any Town, NY
Site Project Manager and Clinical Research Coordinator September 2005 – April 2008
- Participated in pre-study, initiation, day- to- day and close-out functions.
- Participated in SOP’s and documents development.
- Managed clinical trials with excellence and within time expectation. Maintained regulatory files.
- Implemented recruitment strategies per protocol, GCP and ICH guidelines.
- Strong understanding of drug development process.
- Managed all correspondence and electronic submissions of regulatory affairs documents.
- Managed glycemic, lipid, renal and hypertensive regimen per protocol. Monitored labs.
- Interpreted data, wrote and submitted reports.
- Attended Investigator meetings and delivered presentations as required.
- Managed allocated site budget.
Education:
- 10/2006-11/2006 Business Management Course – Northwestern University
- 09/2003-02/2004 Case Western Reserve University-Research Medical Assistant Program
Languages:
Fluent in Chinese.
References
Available upon request
Click to download the Clinical Research Resume Sample One in PDF.
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