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Job Title: Home-based Regional CRA
Job Location: MD: Baltimore
Pay Rate: Open
Job Length: 4-6 months (contract)
Start Date: 2008-03-27
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: Title: Home-based Regional CRA
Company: Pharmaceutical Company
Location: Baltimore, MD (100 mile radius)
Status: Full-time consulting engagement, 40 hrs/week
Length: Long - term assignment in 6 month increments
Our client is a company that wants to be recognized for having a positive
impact on people's lives with their products by meeting needs and
surpassing expectations. The company strives to build a reputation for an
exciting workplace in which all employees and contractors can realize
their professional ambitions.
Delivery of high quality data according to agreed timelines and budget,
ensuring adherence to international and local regulations and company SOP
standards. Demonstrate exceptional customer focus as evidenced by positive
feedback from colleagues and external customers (Investigators).
Participate in the site nomination process; perform evaluation of site
capability to deliver the contractually agreed to number of patients and
high quality data then make recommendation for inclusion in the clinical
trial. Assume ambassadorial role to facilitate communication between
sites and company line functions to increase value proposition to
investigators. Facilitate preparation and collection of site level
do***ents. Execute site initiation and training activities. Perform
monitoring visits according to monitoring plan and author study monitoring
re****ts. Manage site drug supply management. Resolve site level update of
technical systems (ClinAdmin, EDC). Ensure site activities in line with
milestones (i.e. startup, recruitment, closeout, etc). Manage recruitment
implementing appropriate contingency plans as needed. Assure continual
GCP, ICH and company SOP compliance (Informed consent process, source data
verification, AE and SAE re****ting, IN, protocol, drug accountability
etc.). Resolve deviations to standard by remedial action and training.
Perform data query resolution process (both at Site and with Data
Management). Execute site closeout activities. May act as local (or
global) CRA Lead, as assigned. May act as a mentor to new associates for
purposes of field training, as assigned.
Requirements: A degree in a scientific or health care discipline
preferred. Basic medical and business knowledge. Desired competency in
clinical research or having demonstrated adequate level of proficiency
within the CRA II competency profile. Understands and can apply knowledge
of clinical trial designs to trial execution. Knowledge and experience in
international standards (GCP/ICH), international (FDA, EMEA) and local
regulations. Expertise in communication, managing multiple priorities and
computer literacy.
The Cambridge Group, Ltd. offers our contract employees a cafeteria-style,
flexible benefits plan where consultants can choose from:
-Three different Blue Cross Health Plans
-Dental Insurance
-401k
-Life Insurance & AD&D
-Long-term Disability
-Paid Holidays
-Up to 4 weeks of Vacation
-Continuing Education Reimbursement up to $5,250 /yr
-Section 529 Tax-Deferred College Savings Plan
We also offer relocation benefits, H-1 visa, and sponsor****p for permanent
residency (green card) immediately upon hire, as appropriate.
Please refer to Job code CB5422 when responding to this ad.
For FASTEST PROCESSING of your resume, please visit
http://www.jobcircle.com/classifieds/1251689.html?source=ng
to apply
online.
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For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
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