Job Description Summary

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.

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. 

 

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