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Job Title: Home-based Regional CRA - Transplant
Job Location: NY: New York
Pay Rate: Open
Job Length: 4-6 months (contract)
Start Date: 2008-09-03

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 - Transplant



Company: Pharmaceutical Company



Location: New York, NY



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.



The regional CRA will deliver 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 documents. Execute site initiation and training activities. Perform monitoring visits according to monitoring plan and author study monitoring reports. Manage site drug supply management. Resolve site level update of technical systems (ClinAdmin, EDC). Ensure site activities are in line with milestones (i.e. startup, recruitment, closeout, etc). Manage recruitment implementing appropriate contingency plans as needed. Assure continual GCP, ICH and SOP compliance (Informed consent process, source data verification, AE and SAE reporting, 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. Monitors with transplant experience required. 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 sponsorship for permanent residency (green card) immediately upon hire, as appropriate.

Please refer to Job code CB5579 when responding to this ad.

For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1435725.html?source=ng to apply online.

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