Position Summary: The Clinical Safety Coordinator is responsible for delivering high quality and compliant day-to-day operational support for the Clinical Safety team 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.

Key Job Responsibilities: 

• Provide operationalsupport for Clinical Safety management activities for BDPI clinical studies to enable successful completion of study objectives and deliverables.  

• Ensure quality and compliance for safety-related activities performed for assigned clinical studies ensuring the highest standards for scientific quality, integrity and ethics are met and that these are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations. 

• Develop and maintain strong relationships with investigational site staff, HCP consultants (e.g., Medical Monitors, CEC/DMC members), and cross-functional study teams to support Clinical Safety deliverables.

• Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, CRAs), as needed.  

• SupportTrial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.

• Support the Clinical Safety team withother administrative tasks (e.g., collection of study documents, Confidentiality Disclosure Agreement requests, HCP Consulting Agreements, etc.) as needed, to facilitate the conduct of the study.

• Support the management of study-specific tracking reports for Clinical Safety, as needed, to ensure Clinical Safety reporting is completed compliantly and that other Clinical Safety deliverables are completed within study-specific timelines and budgets for assigned clinical studies. Provide regular Clinical Safety status updates to relevant BD and study partners.

• Support the development and completion of study-specific Clinical Safety Plans, Medical Monitor Approval Forms, Clinical Events Committee (CEC) Charters, Data Monitoring Committee (DMC) Charters, and other safety-related study documents, as needed.

• Support the reporting and escalation of BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact data collection.  

• Support safety-related interactions, training and invoicing for Medical Monitors, CEC Members, DMC Members and other Clinical Safety vendors.

• Participate in and/or support study-specific meetings including, but not limited to Safety Event Trending Meetings, CEC Adjudication/Meetings, DMC Meetings, safety-related study team meetings, and vendor meetings.

• Provide support for issue partner concern related to Clinical Safety.

• Interact with investigational sites, vendors, and other functional areas for issues, as needed.

• Proactively identify issues and create mitigation strategies in collaboration with Clinical Project Management and other leadership.

• Provide support forinternal or external audits/inspections andensure resolution of audit/inspection findings related to Clinical Safety activities.

Required Qualifications:

• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)

• Strong interpersonal and communication/presentation (oral and written) skills

• Strong organizational skills, attention to detail, critical thinking and analytical skills

• Able to lead and delegate multiple tasks and prioritize importance of tasks/projects

• Ability to travel up to 10% (or more during peak times)

Preferred Qualifications:

• Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies

• Knowledge of clinical study processes and systems (eTMF, CTMS and CDMS). Prior experience with Veeva Vault preferred.

• 1+ years of experience with clinical safety management or medical device safety reporting

• Experience with medical device studies

• Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)

Education and/or Experience:

• Bachelor’s Degree (BS/BA)in life sciences,nursing, a related healthcare field equivalent OR a related certification in cardiology or radiologyor equivalent combination of training and experience (MA/MS preferred)

• 1+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology), with clinical safety management, medical device safety reporting, or in a clinical setting

Physical Demands: