Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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

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

• Accredited Certification in Good Research Practices is require

• 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 i