Job Description SummaryThe Senior Clinical Research Associate (CRA) will act as a liaison between BD (the study Sponsor) and the sites/clinics that conduct their assigned clinical studies. Focused primarily on ensuring data quality and regulatory compliance, the CRA will work closely with the Principal Investigator and their staff at their assigned clinical study sites. The Senior CRA will identify and/or resolve data queries and will ensure identification and reporting of safety events and/or device deficiencies. Requiring little supervision, the Senior CRA will review site files and processes to ensure that applicable regulations are being followed. They will actively participate in site identification and qualification activities. Assigned studies tend to be larger, more complex studies used to support device registrations.Job 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.BD Surgery aims to increase physician satisfaction and to assist hospital and surgery centers to improve outcomes and lower cost with a product portfolio that aligns with the patient’s needs. The business unit focus on preoperative and intraoperative solutions including patient preoperative skin prep, intraoperative irrigation, hemostatic agents and sealants, as well as hernia repair mesh and fixation systems.The Senior Clinical Research Associate (CRA) will act as a liaison between BD (the study Sponsor) and the sites/clinics that conduct their assigned clinical studies. Focused primarily on ensuring data quality and regulatory compliance, the CRA will work closely with the Principal Investigator and their staff at their assigned clinical study sites. The Senior CRA will identify and/or resolve data queries and will ensure identification and reporting of safety events and/or device deficiencies. Requiring little supervision, the Senior CRA will review site files and processes to ensure that applicable regulations are being followed. They will actively participate in site identification and qualification activities. Assigned studies tend to be larger, more complex studies used to support device registrations.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 requirements and tasks
Support audit activities, as appropriate
Ensure site(s) maintains an acceptable inventory of clinical supplies and associated documentation
Rigorously maintain compliance with the company’s business travel and expense policies
EDUCATION AND EXPERIENCE
Bachelor’s Degree or higher in a healthcare or science related field. Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need
Good Clinical Practices (GCP) certification from an accredited program is required
2+ years of relevant clinical research experience as a field-based CRA is required; medical device experience is preferred
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
Ability to master understanding of the disease state and product(s) under investigation
Primary Work Location and Additional Considerations:
REMOTE / Field-based position
Ability to work independently from a home office.
Ability to travel 50% of the time is required.
Must possess and maintain a valid driver's license and a past clean driving record for a minimum of 3 years; as well as meet BD's auto safety standards
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor Visas' at this time.
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide Relocation assistance at this time.
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.#earlycareerPrimary Work LocationUSA NJ - Franklin LakesAdditional LocationsWork ShiftNA (United States of America)Becton, 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.
