Job Description Summary

The purpose of the Clinical Research Associate position is to provide Study Monitoring for clinical studies sponsored and conducted by UCC Medical Affairs. Clinical studies may range from simulated use studies (employing a clinician to use the device in a simulated environment) to complex studies in human subjects.

Job Description

We are the makers of possible 

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. 

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. 

Summary

The role of the CRA is to ensure compliance with all applicable regulatory requirements as well as company SOPs/ICH GCP in the conduct of clinical research. The CRA must always act in the best interest of the patient and implement to all relevant regulations when interacting with patients, investigators and other collaborators.  As representative of the company, the CRA must exhibit the highest level of professionalism at all times.  

Responsibilities

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.  

• Performs clinical study site management/monitoring/training activities in compliance with ICH-GCP, Sponsor SOPs, IRB/EC policies and procedures, Local Laws & Regulations, Protocol, Clinical Monitoring Plan and study-specific documents.  

• Gains an in-depth understanding of the study protocol and related procedures.

• Possesses a working knowledge of the disease state and product(s) under investigation

• Authors study-specific Clinical Monitoring Plan and other study-specific documentation and training materials, aligned with the study protocol

• Participates & provides inputs on site feasibility and selection activities.  

• Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated are accurate and subjects are protected.  

• Conducts site visits including but not limited to qualification visits, initiation visits, interim monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.  

• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

• Assists with maintenance of the Trial Master File (TMF)

• Ensures site maintains an acceptable inventory and accountability of study devices and clinical supplies  

• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.  

• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CAPA and Escalation Pathways as appropriate

• Completes and maintains relevant global Medical and Clinical Affairs, BU-specific, and study-specific training

Education and Experience

• Bachelor’s degree or higher in a healthcare or science related field

• At least 2 years of relevant clinical research experience and direct site management (supervising) experience in the device/pharmaceutical industry, including multi-phase business knowledge of product development

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

• Working knowledge of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.

• Solid understanding 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 organisational change approaches with a growth mindset

• Demonstrated ability to prioritize multiple tasks with challenging timelines and deliverables

Travel

• Ability to travel approximately 50%

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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/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.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

USA NJ - Franklin Lakes

Work Shift