Clinical Research Associate

Additional Location(s):   N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                About the role: Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start up, enrollment, follow up and closure of clinical trial activities.    Relocation: Relocation assistance is not available for this position at this time. VISA: Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.   Your responsibilities will include:

Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies. Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records. Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required. Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations. Collaboration: participates in study-specific meetings, teleconferences and trainings.Collaborates with cross-functional team members and study sites throughout all study phases. Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.

Required qualifications:   • University degree or the equivalent combination of education and experience required • 1-3 years relevant experience     Requisition ID: 631279   Minimum Salary: $ 71500   Maximum Salary: $ 135800     The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.   Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other