Regional CRA - New England area

Biotechnology and Pharmaceutical Regional CRA - New England area Job Description:Regional CRA - New EnglandDelivering on the promise of medical innovation begins at Boston Scientific! By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce. General Summary: 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: 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. Assure 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. Assist monitoring project manager and trainer by planning and developing training materials. 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 – Qualification visit: This is 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 – Initiation Visit: All documentation should be in. Review protocol and devices. Lay out sponsor expectations of study. Ready to enroll patients. Third visit -- Intermonitoring visit: This consists of multiple visits. Monitoring CRF (Case Report Forms) against source document, review informed consent. Review site binder. This is the 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 – Close outs: When study has ended. Database locked. Correct original copies of documents. Report submitted to IRB (Internal Review Board) Work with in-house project teams All Visits: Write reports; jet form. Letter to sites prior to visit. Follow up letter to site. Fill out transmittal forms to send these documents to BSC. Minimum Education & 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: Travel up to 60% - typically 10 days per month on site Home officeJob Experience:Minimum Education & Experience: • Bachelor of Science degree in health/science related field • 2-4 years of monitoring experience • Basic computer skills • Knowledge of CRF 21Minimum Education Required: BachelorYears of Experience Required: 3-5 YearsExpected Travel Time: None Please visit us online at www.bostonscientific.com for more information.