Job Description SummaryJob DescriptionWe are the makers of possibleBD 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.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.DESCRIPTION:Under the direct supervision of the Manager, Monitoring Operations, the Clinical Research Associate (CRA) will:
Provide monitoring oversight to the project team and effectively manage assigned clinical site(s)/project(s).
Build and maintain successful working relationships with internal partners and site staff, e.g. investigators, coordinators.
Display confident understanding of (CPSP) protocol and accompany background product information, (e.g. IB, RPI, etc.).
Possess a working knowledge of the disease state and product(s) under investigation.
Perform all types of on-site/virtual/remote/in-house monitoring activities and visits (e.g. qualification, initiation, Interim monitoring, and closeout) according to plan. Conduct source document review/verification (SDR/SDV) per plan.
Oversee and ensure site staff implement study according to CPSP (protocol) and in compliance with regulatory requirements/standards (GCP/ISO), IRB/EC policies and procedures, and BD-established standards.
Ensure patient safety is maintained and informed consent procedures are carried out and documented properly.
Adhere to monitoring visit cycle times as instructed in procedural documents, e.g. Clinical Monitoring Plan.
Rigorously maintain compliance with the company’s business travel and expense policies.
Review/report AE/SAEs and protocol deviations per industry and BD standards.
Maintain complete and audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters, e.g. ALCOA.
Actively participate in the site feasibility and selection process.
Produce proficient and timely documentation of monitoring activities/visits, e.g. trip reports within company-specified quality standards.
Support, as needed, regulatory submission activities.
Collaborate actively with other BD functions, e.g. DM, Statistics.
Maintain all project supporting systems, e.g. CTMS, CDMS, etc.
Coordinate, develop, and deliver site-facing presentation materials, Investigator Meetings, Initiation visits, etc.
Ensure site staff are adequately trained in all project-related requirements and tasks.
Participate in audit activities, as appropriate.
Proactively identify, call out, and handle risks and issues to ensure compliance. Communicate internally and externally to ensure adequate knowledge sharing and operational continuity.
Contribute to continuous improvement activities/initiatives and standard process sharing.
Ensure site(s) maintain an acceptable inventory of clinical supplies.
Routinely review and assess site equipment to ensure proper certification, calibration, and pertinent operational standards are maintained.
BASIC QUALIFICATIONS:
Bachelor’s Degree or higher in a healthcare or science related field.
2 years of relevant clinical research experience as a field based CRA in the device/pharmaceutical industry, including a multi-phase business knowledge of medical device or pharmaceutical product development
Consideration of a candidate with any alternate level of education will be case dependent based on experience and positional need.
Experience with IVD and point of care studies highly desirable.
Laboratory experience in molecular biology, microbiology and blood culture highly desirable.
Ability to travel, approximately 50%
COMPETENCIES:
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.
Working knowledge of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
Working knowledge of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPPA
Ability to work in and promote team cohesiveness in a virtual/remote environment.
Exhibit flexible change management approaches with a growth mindset.
Demonstrated ability to prioritize multiple tasks with competing timelines and deliverables.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careersBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.PDNPrimary Work LocationUSA MD - Sparks - 7 Loveton CircleAdditional LocationsWork ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
Full-time