US-MA: Boston-Regional CRA
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Job Title: Regional CRA
Job Location: MA: Boston
Pay Rate: Open
Job Length: full time
Start Date: 2008-07-06
Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856
Description: Regional CRA
The regional CRA will assure investigational site compliance with divisional clinical protocols, SOP’s, GCP and FDA guidelines and actively participates in clinical trial site implementation and training. Duties and responsibilities include: independently performs investigational site qualifications, initiations, monitoring and closeout visits according to study requirements SOP, GCP and FDA guidelines within the timelines required by the clinical divisions, assists monitoring project manager in planning site visit schedule, assuring quality, accuracy and complete reporting of clinical events and data by the investigational sites, takes initiative in identifying project-specific site and monitor training needs to assure site compliance. Independently performs investigational site training on study and regulatory requirements related to the conduct of a clinical trail and the investigator obligations through monitoring visits, query resolution and deviation reporting, assists monitoring project manager and trainer by planning and developing training material, accurately reports, documents and files all relevant investigational site visits and activities within the timelines required by the clinical division, assists data management in the preparation of documents and collection of trial data from the investigational sites and actively contributes to the resolution of CEC and DSMB required information, contributes to the implementation of clinical trials by assisting the team in developing and reviewing study-specific documents and manuals necessary to the conduct of the trial. First visit will consist of: prior to site participation in the study; set up visit with doctor and site coordinator; locate site and office; check for adequate facilities, time, interest, operating procedures, issues that might cause problems down the road- this is when it is determined whether the site meets qualifications to be accepted as part of the study; review protocol, review private investigator’s credentials, make recommendation on whether to include site in the study. Second visit – all documentation should be in, review protocol and devices. Lay out sponsor expectations of study. Ready to enroll patients. Third visit - monitoring CRF (Case Report Forms) against source document, review informed consent. Review site binder; which contains IRB information and correspondence. Review Lab certification, CV’s medical licenses. All information must be current. Regulatory binder -- look for outstanding issues (follow up) DCF’s, meet with Private Investigator and discuss trial; one to two days at each site. Check device accountability -- device account: serial numbers, secured site. Duplicate documents at site for inclusion in our regulatory binder. Regulatory and site binder should match, annual reviews done and approved. Provides checks and balances of trial. Varies per monitor plan per site. First visit 2 weeks after enrolled - some every 30 days, some every 90 days, depends on needs of site, collect CRFS and documents and send to data entry people. Final Visit will happen when study has ended. Database locked; correct original copies of documents. Report submitted to IRB (Internal Review Board) Work with in-house project teams. After all visits- write reports; jet form, letter to sites prior to visit. Follow up letter to site. Fill out transmittal forms to send documents to office. Minimum education and experience: Bachelor of Science degree in health/science related field, 2-4 years of monitoring experience, basic computer skills, knowledge of CRF 21. Working Conditions include travel up to 50% - typically 10 days per month on site home office. Locations include: New England, Missouri/Iowa and Georgia.
Please refer to Job code BG5520 when responding to this ad.
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