Responsibilities:
The Senior Clinical Research Associate (CRA) will participate in activities specific to regulatory compliance/HDE focus within Boston Scientific’s Neurovascular Division as well as participate in the site qualification/initiation process, including scheduling monitoring activities with site personnel. Assist management with the development, negotiation, and execution of the site contract, budget and payment plan, with final approval from Clinical management. Assist Clinical management with development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees. Draft informed consents under direct supervision. Gather documents and information for clinical investigator and laboratory selection. Manage device accountability, inventory, and distribution. Manage the oversight of device complaint/malfunction process and tracking. Monitor on-going compliance to study protocols and site adherence to global regulatory guidelines. Prepare and participate in presentation of protocols and other study conduct requirements at study initiations at investigational sites when needed. Oversee subject screening and enrollment at assigned clinical sites. Manage distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness. Track and report progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ’s. Assist in query writing and resolution process, as required. Identify and gather missing or incomplete data from the investigational sites. Prepare Clinical Risk/Benefit Analysis (CRBA) under the direction of clinical management. Assist clinical project manager with developing/maintaining project timeline, managing study budget, and preparing routine operations reports. Assist clinical project manager with core lab activities and data monitoring committee responsibilities. Conduct site visits, as necessary. Coordinate Clinical staff in the oversight of site compliance including the development and implementation of corrective actions for addressing noncompliance issues. Assist Clinical staff in identifying sites to be audited by either Corporate Compliance or Clinical staff. Assist with study site audits. Track regulatory agency audits of investigational sites and analyzes outcomes. Assist Clinical management with regulatory submissions, and other reports as required. Oversee on-going literature searches; perform therapeutic area/product specific reviews. Assist with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions.

Minimum Education & Experience:
Bachelor level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. Master’s degree preferred. A minimum of 5 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required. 2-3 years of clinical monitoring experience required. Project management experience preferred.df-dg

Responsibilities:
The Senior Clinical Research Associate (CRA) will participate in activities specific to regulatory compliance/HDE focus within Boston Scientific’s Neurovascular Division as well as participate in the site qualification/initiation process, including scheduling monitoring activities with site personnel. Assist management with the development, negotiation, and execution of the site contract, budget and payment plan, with final approval from Clinical management. Assist Clinical management with development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees. Draft informed consents under direct supervision. Gather documents and information for clinical investigator and laboratory selection. Manage device accountability, inventory, and distribution. Manage the oversight of device complaint/malfunction process and tracking. Monitor on-going compliance to study protocols and site adherence to global regulatory guidelines. Prepare and participate in presentation of protocols and other study conduct requirements at study initiations at investigational sites when needed. Oversee subject screening and enrollment at assigned clinical sites. Manage distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness. Track and report progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ’s. Assist in query writing and resolution process, as required. Identify and gather missing or incomplete data from the investigational sites. Prepare Clinical Risk/Benefit Analysis (CRBA) under the direction of clinical management. Assist clinical project manager with developing/maintaining project timeline, managing study budget, and preparing routine operations reports. Assist clinical project manager with core lab activities and data monitoring committee responsibilities. Conduct site visits, as necessary. Coordinate Clinical staff in the oversight of site compliance including the development and implementation of corrective actions for addressing noncompliance issues. Assist Clinical staff in identifying sites to be audited by either Corporate Compliance or Clinical staff. Assist with study site audits. Track regulatory agency audits of investigational sites and a

Other desired skills:
clinical research associate, project manager, IRB, protocol, site initiation, cra, medical device