Senior Clinical Research Associate

Responsibilities

• 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
• Performs 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)
• Interacts with prioritization of subject safety including appropriately administered informed consent
• Reviews and reports adverse event/safety events and protocol deviations per industry and BD standards
• Maintains audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters
• Maintains all project supporting systems, e.g. CTMS, EDC, eTMF, etc.
• Produces proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards)
• Collaborates with the studies cross-functional team members and actively participates in meetings
• Aids in the development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc.
• Ensures site staff are adequately trained in all project-related requirements and tasks
• Supports audit activities, as appropriate
• Ensures site(s) maintains an acceptable inventory of clinical supplies and associated documentation

Requirements

• Bachelor's Degree or higher in a healthcare or science related field AND 2+ years of relevant clinical research experience is required - OR - Associate's Degree or higher in a healthcare or science related field AND 3+ years of relevant clinical research experience is required
• Good Clinical Practices (GCP) certification from an accredited program is required
• Medical device experience is preferred

Education And Experience

Education and experience requirements as outlined above.

Knowledge And Skills

• Fluent knowledge of spoken and written English language, including medical terminology
• Superior written and verbal communication skills
• Proficiency in presentation preparation and delivery
• Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance
• Previous experience with EDC, CTMS and eTMF systems required
• Understanding of clinical study management processes and systems, including monitoring, investigational product handling, data management, etc.
• Understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPAA
• Ability to work in and promote team cohesiveness in a virtual/remote environment
• Exhibit flexible organizational change approaches with a growth mindset
• Demonstrated ability to prioritize multiple tasks with challenging timelines and results
• Mastering understanding of the disease state and product(s) under investigation

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.