Field-based Sr. Clinical Research Associate - SE – Atlanta

Senior Clinical Research Associate (field-based) – Cardiovascular – Southeast Region – Take your clinical experience to the next level!

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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:

• Monitors clinical trials and manages clinical sites for compliance with study requirements, BSC SOPs, GCP and FDA guidelines within the timelines required by the clinical therapeutic areas. Oversees multiple protocols with a variety of research sites. Works with Clinical Monitor Manager to monitor compliance with Monitoring Plan for all studies and assists with planning site visit schedule. May be required to conduct site visits outside geographic area to ensure compliance with the Plan, meet study timelines and function as a mentor.
  
• Assure proper conduct of the study, 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. Assists Clinical Monitor Manager in providing supplemental training to sites and/or other monitors.
  
• Initiates investigational sites and performs ongoing 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 Clinical Monitor Manager 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 therapeutic area.
  
• Collects trial data from the investigational sites necessary for CEC and DSMB activities.
  
• 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, including case report forms, subject visit worksheets, and monitor tools.
  
• Acts as backup for Clinical Monitor Manager by serving as alternate contact. Provides clinical and technical support for other monitors as a mentor.
  
• Participates in special assignments to facilitate quality enhancement of the clinical trial process.
  
• Represents monitoring team at Investigator Meetings and delivers GCP-related training as directed by the project team and Clinical Monitor Manager
  
• Independently troubleshoots issues and makes decisions within project assignments.
  
• Adapts to changing priorities and independently motivates self and others to complete tasks in an accurate and timely manner.
  
• First Visit – Qualification visit: This is prior to site participation in the study. Locate site and office. Check for adequate facilities, time, interest, 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
  
• Second Visit – Initiation Visit: All documentation should be in. Review protocol and devices. 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. Reg 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 o
  
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