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Job Title: Mgr. Clinical QA Training and Audits
Job Location: CT: Wallingford
Pay Rate: Open
Job Length: full time
Start Date: 2008-03-28
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: Mgr. Clinical QA Training and Audits
The primary focus of this position will be the development and
implementation of training and related activities for Clinical Functional
Area (CFA) polices / procedures along with topics related to Good Clinical
Practices (GCPs). A secondary focus will be to conduct and / or oversee
Good Clinical Practice (GCP) *****sments / audits and to liaise with
Clinical Functional Area (CFA) and Regulatory Affairs personnel for
assigned protocols / projects on GCP issues in sup****t of clinical trial
activities. Responsibilities include: ensure that clinical trials
do***entation, study data and investigative procedures conform to
applicable regulatory requirements, guidelines, company policies /
procedures to assure high quality, approvable submissions; participate in
the planning and implementation of the clinical quality plan; develop,
implement and provide oversight of a CFA training system in order to ensure
CFA personnel adherence to training matrix requirements through appropriate
management and maintenance of the training process and materials according
to CFA polices / procedures; store and provide access to CFA and GCP
training materials, including audio / video presentations, quizzes;
appropriately do***ent training attendance and completion; develop, update,
conduct and do***ent GCP training of new personnel, contract and / or
clinical site personnel regarding appropriate regulations, guidelines,
company policies / procedures and industry standards. Qualifications
include: a BS in a biomedical science or equivalent education with 2 - 3
years experience, or an MS degree in a biomedical science or equivalent
education and 1 -2 years experience, in medical research related
activities; familiar with approaches to effective training and systems used
to do***ent and track successful completion of training sessions; possess
effective training and communication skills to be able to ensue effective
presentation and comprehension of training sessions and materials;
knowledgeable of FDA regulations and ICH GCP guidelines regarding the
conduct and re****ting of clinical trials; knowledge of the ex-US health
authority requirements and guidelines a plus (EU, Australia, Japan, etc);
knowledge of biomedical statistics and current e-technologies related to
clinical trial activities is helpful.
Please refer to Job code SD5265 when responding to this ad.
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online.
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