Clinical Research Associate II

• Provide site management and monitoring support for BDPI clinical studies
• Ensure quality, compliance, scientific integrity and ethical conduct of assigned clinical studies
• Conduct on-site or remote clinical site monitoring activities
• Evaluate sites for qualification or activation and review informed consent forms and subject data
• Issue and address data queries and elevate study non-compliance issues
• Verify corrective actions, investigational product accountability and regulatory approvals
• Review essential study documents and conduct study training and presentations
• Ensure timely reporting of reportable events and adequate study supplies
• Serve as a product, procedure and clinical study protocol resource for BD stakeholders and investigators
• Develop and maintain relationships as the primary site contact
• Facilitate communication among clinical sites, BD stakeholders and cross-functional study teams
• Develop and manage study-specific tracking reports
• Perform Trial Master File audits and resolve or elevate TMF quality issues
• Assist with Clinical Trial Management System management
• Prepare and complete clinical study activation, monitoring, training, accountability and other essential documents
• Provide input on clinical project management, data management, statistics, safety, product and supplier documents
• Identify opportunities to improve clinical study performance and provide cross-functional feedback
• Communicate product complaints and other study-impacting events to BD stakeholders
• Participate in or lead study, CRA and vendor meetings
• Support clinical project management with administrative tasks
• Identify issues and create mitigation strategies with Clinical Project Management and leadership
• Support internal or external audits and inspections
• Support continuous improvement and best-practice initiatives
• Mentor Site Management & Monitoring personnel and conduct monitoring evaluations or co-monitoring visits

Requirements

• Bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
• 3+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
• 2+ years of experience with site management & monitoring or managing clinical projects
• Knowledge of domestic and international clinical research regulations and guidelines
• Knowledge of Good Clinical Practice (ICH GCP/ISO14155) and current industry practices
• Proficiency with Microsoft Suite tools, including Outlook, Word, Excel, PowerPoint, OneNote, To-Do and SharePoint
• Strong knowledge of clinical study processes and systems, including eTMF, CTMS and CDMS
• Strong interpersonal and communication/presentation skills
• Strong organizational, attention to detail, critical thinking and analytical skills
• Ability to manage and delegate multiple tasks and prioritize tasks/projects
• Ability to travel up to 60% or more during peak times
• Role may be hired anywhere in the United States
• Must live within 45 minutes of an international airport

Core Competencies

Demonstrates expertise in clinical study management, including site monitoring, compliance with regulations, and effective communication with stakeholders. Proficient in utilizing clinical trial management systems and ensuring the integrity of clinical data.

Highest-signal resume keywords

• Clinical Research Experience
• Site Management & Monitoring
• Good Clinical Practice (ICH GCP/ISO14155)
• Clinical Trial Management System (CTMS)
• Microsoft Suite Proficiency

Hard Skills

• Clinical Study Processes
• Data Management
• Regulatory Compliance
• Investigational Product Accountability
• Trial Master File Audits
• Study Training and Presentations
• Data Query Resolution
• Study-Specific Tracking Reports
• Critical Thinking
• Analytical Skills

Soft Skills

• Interpersonal Skills
• Communication Skills
• Organizational Skills
• Attention to Detail
• Leadership

Industry Keywords

• Clinical Research Regulations
• Medical Device
• Pharmaceutical
• Biotechnology
• Clinical Study Protocol

Tools & Technologies

• ETMF
• CDMS
• Microsoft Outlook
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft OneNote
• Microsoft To-Do
• Microsoft SharePoint