Job Description Summary

The Senior Clinical Research Associate is responsible for delivering high quality and compliant site management & monitoring for clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention business unit to ensure they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations. The Senior Clinical Research Associate will be responsible for the day-to-day management and oversight of assigned clinical sites, performing on-site and remote monitoring visits, driving recruitment, providing technical/troubleshooting support and for developing strong relationships with clinical site personnel including Investigators, study coordinators, nurses and other site staff. The Senior Clinical Research Associate will also lead and/or support Clinical Project Management with other study development, study start-up, study conduct/maintenance and study close-out activities including the review and development of essential clinical study documents.



This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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. 

Job Responsibilities:

• Provide Site Management & Monitoring support for BDPI clinical studies to enable successful completion of study objectives and deliverables.   

• Ensure quality and compliance for assigned clinical studies and study activities performed at assigned clinical sites, ensuring the highest standards for scientific quality, integrity and ethics are met and that these are conducted according to BD global clinical procedures, study protocols, GCP and all applicable regulations.  

• Conduct on-site or remote clinical site monitoring activities for assigned clinical sites to evaluate sites for qualification or activation, review informed consent forms, review subject data for accuracy, issue and address data queries, ensure study is conducted compliantly, address/escalate study non-compliance issues, verify that any corrective actions are implemented, perform investigational clinical product accountability, ensure proper regulatory approval, review essential clinical study documents for completion/accuracy, conduct study training/presentations, ensure proper training documentation, ensure timely reporting for reportable events (e.g., Unanticipated Adverse Device Effects, device deficiencies, etc.), ensure good documentation/clinical practices (GDP/GCP), ensure study supplies are adequate and perform other site management & monitoring activities, as needed. 

• Serve as a product, procedure and clinical study protocol expert and resource for BD stakeholders, Investigators, and study site personnel.   

• Develop and maintain strong relationships with investigational site staff, hospital personnel, and cross-functional study teams to support study deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, Clinical Field Specialists, Contract Managers), as needed.   

• Develop and manage study-specific tracking reports to detail clinical study progress (e.g., screening/enrollment status, site activation status, SDV status, etc.), as required, to ensure Site Management & Monitoring deliverables are completed compliantly, within study-specific timelines and within budgets for cl