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Accountancy
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0 Finance, Insurance
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0 Construction, Property
0 Customer services
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Section: Accountancy Vacancy 1659 |
Post:Quality Assurance Manager |
Salary contractual |
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Requirements and conditions |
Age: |
Has no value
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Gender |
Has no value
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Education: |
no
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Work schedule: |
Has no value
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Work place: |
London
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The announcement text: |
The Cardiovascular Research Foundation, headquartered in New York City, has been dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine for over fifteen years.
By establishing the safe use of new technologies and pharmacologic agents, CRF has played a major role in the remarkable advances in survival and quality of life being realized for patients with cardiovascular disease.
Become a part of our team and help CRF serve as a major catalyst in the field of interventional vascular medicine.
Quality Assurance Manager
Job Description:
Under the supervision of the Quality Assurance Director, the Manager of Quality Assurance is responsible for working with regulated departments to facilitate the establishment of and adherence to training programs. Responsibilities include, but are not limited to:
• Assists with clinical audit preparation, including client, vendor and study audits.
• Performs clinical site audits for clinical trials managed or sponsored by the Cardiovascular Research Foundation.
• Implements Quality Assurance plans and audits for ongoing projects and studies. Performs internal GCP, database and other audits as required for ongoing clinical studies. Audits various clinical trial functions for compliance to guidelines.
• Uses knowledge of FDA and other regulations and guidelines as applicable, to perform job functions.
• Develops, distributes and manages Standard Operating Procedures and Work Instructions for various CRF departments.
• Facilitates and responds to client audits.
• Works with CRF regulated departments to facilitate establishment of and adherence to training programs. Manages training documentation for CRF regulated departments.
• Responsible for the validation of CRF systems, including software and databases.
• Participates in a wide variety of special projects to fulfill responsibilities in accordance with the CRF Standard Operating Procedures (SOPs), ICH guidelines, and applicable FDA regulations.
• Compiles a variety of special reports and ensures that all study documentation is maintained in a compliant manner.
Job Requirements:
BS, preferably in the life sciences or related discipline. 2 - 3 years as a GCP auditor or Quality Assurance professional with auditing background, or equivalent experience. Thorough knowledge of GCP guidelines, federal regulations and other applicable guidelines; knowledge of interventional cardiology a plus. Proficient with Microsoft Outlook, Word, Access and Excel. Ability to analyze information and solve problems relating to all processes within a clinical research environment. Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike. Ability to set priorities and excellent organizational planning, project management and time management skills. Willingness to learn applicable regulations and expand job and industry-related knowledge.
Benefits:
• Choice of health plans that include medical, dental and vision coverage.
• Company-paid short-term and long-term disability and life insurance.
• Health and dependent care flexible spending accounts.
• Pre-tax travel expenses through TransitChek program.
• 401(k) plan.
• Generous paid time off (PTO) entitlement CRF employees accrue four weeks of PTO in first year of employment; five weeks of PTO in the second through fourth years.
• Ten paid holidays each year.
Contact Information:
To be considered for this opportunity, please submit your resume, including salary requirements and availability to the Recruiter-fax (212) 851-9280 or email to job@crf.org. Please refer to job title "Quality Assurance Manager " in your cover letter.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org
CRF is an equal opportunity employer.
Principals only. Recruiters, please don`t contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.
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Contact information |
Employer: |
Êîíñàëòèíãîâîå àãåíòñòâî "Ýôôåêòèâíûé Ïîäõîä"
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Email: |
job@crf.org.
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Phone: |
(044) 289 67 95
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Publication date: 2010-02-02 05:22:43
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