SeniorClinicalResearchAssociate

**We are the people who give possibilities purpose** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. # Job Description **Responsibilities include, but are not limited to:** * Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators) * Acts as the primary liaison between BD and the investigational site * Perform all types of monitoring visits (i.e., on-site, virtual/remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to plan * Conducts source document verification per plan * Routinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and procedures * Site interactions involve prioritization of subject safety including appropriately administered informed consent * Review/report AE/SAEs and protocol deviations per industry and BD standards * Maintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters * Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc * Produce proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards) * Collaborate with the studies cross-functional team members and actively participate in meetings * Assist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc. * Make sure site staff are adequately trained in all project-related requi