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Job Title: Sr. Auditor Clinical QA
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: Sr. Auditor Clinical QA
The primary focus of this position 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. You will also facilitate CFA policy / procedure development,
implementation and maintenance in addition to participating in the
development and presentation of CFA policy / procedural materials along
with topics related to GCPs. Responsibilities include: ensure clinical
trials do***entation, study data and investigative procedures conform to
applicable regulatory requirements, guidelines, company policies;
participate in the planning and implementation of the clinical quality
plan; provide guidance to project teams on GCPs; review clinical trial
information for assigned projects / protocols and determine consistency
with applicable regulatory requirements, guidelines, company policies /
procedures; advise, as appropriate, on Health Authority submission
requirements; organize, present and implement Clinical Trial Audit Plans
for assigned projects / protocols; independently conduct and/or oversee
the conduct of clinical investigator site audits; communicate compliance
issues relative to the quality of the company’s clinical trial activities
to management; manage contracted vendors and / or consultants as
necessary; provide budgetary input as related to assigned projects /
protocols, contracted vendors and / or consultants; participate in the
development, implementation and maintenance of CFA policies / procedural
do***ents; participate in the development and presentation of CFA policy /
procedural materials along with topics related to GCPs. Qualifications
include: a BS in a biomedical science or equivalent education with 2 - 3
years experience in medical research / compliance related activities, or
an MS degree in a biomedical science or equivalent education and 1 -2
years experience, in medical research / compliance related activities;
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 SD5266 when responding to this ad.
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online.
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