**************************************************************
JobCircle.com is a regional job board serving all industries
and occupations in the PA, NJ, DE, NY, MD, and DC areas.

We offer a regional job board, online learning, and regional
job fair events for jobseekers who live in our areas of focus.

To Learn More:

Job Board: http://www.JobCircle.com?source=ng
eLearning: http://www.JobCircle.com/courseware?source=ng
Job Fairs: http://JobCircleJobFairs.com?source=ng

**************************************************************

Job Title: Clinical Research Associate II
Job Location: CA: Lemon Grove
Pay Rate: Open
Job Length: full time
Start Date: 2008-07-22

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Clinical Research Associate II



The Clinical Research Associate II (CRA II) is responsible for planning, implementing, and monitoring of clinical studies in all phases of drug development. Duties include: implement and monitor clinical studies in all phases of drug development, participate in or conduct Pre-Investigational, Study Initiation, Site Monitoring, and Study close-Out visits at study sites, maintain communication with clinical department, investigators and clinical sites and contract clinical monitors, collect and review of regulatory and site documents prior to study initiation and during study conduct, prepare all study binders prior to Study Initiation, prepare drug shipment requests for study drug shipments from vendors to study sites, verification of study drug accountability completeness at site visits, ensure case report forms (CRFs) are accurate, complete, and verifiable against source documents, verify study site screening and enrollment logs are complete and current, participate in collection of data relative to serious adverse events, ensure site compliance with the protocol, CRFs, GCP's, resolution of data queries, and overall clinical objectives, track clinical data, regulatory documents, patient enrollment, and data resolutions to assist the timely completion of clinical studies, assist in the creation of model informed consents, case report forms, instruction manuals, and monitoring tools, assure regulatory compliance of investigational sites with company SOP's, FDA, and ICH guidelines, write visit reports and follow-up letters to investigators, set up files, archive study documentation, correspondence and completed case report forms, enhance professional growth and development through participation in education programs, current literature, in-service meetings and workshops, comply with established company policies and procedures, objectives, quality assurance program, safety, and environmental standards, provide technical and administrative assistance to the clinical department and attend seminars / conferences as required to keep up to date with clinical knowledge. The successful candidate will have a combination of the following skills and experiences: Bachelor's degree in a clinical or health related field, in life sciences or equivalent qualifications. Prefer RN or BSN, requires 3+ years prior experience in monitoring and managing clinical sites and 1 year prior in-house experience with a CRO, a pharmaceutical or biotech company. Knowledge of PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, Windows, MS Office (Outlook, Word, Excel, PowerPoint) are needed. Travel may be required up to 30%% of the time.

Please refer to Job code EG5689 when responding to this ad.

For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1510189.html?source=ng to apply online.

**************************************************************
For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
**************************************************************