Clinical Research Associate II

Jobtailor; Deutschland; Hybrid; EUR 78.000 - 112.000; Vollzeit

Zusammenfassung

BDPI is seeking an experienced Site Management & Monitoring professional to oversee clinical studies, ensuring quality, ethical conduct and regulatory compliance. You will conduct on-site or remote monitoring, qualify sites, review documents and address data queries, while mentoring staff and driving process improvements.

The role requires 3+ years in clinical research and strong knowledge of GCP/ISO14155, CTMS/CDMS/eTMF, with up to 60% travel and eligibility to work in the United States.

Qualifikationen

• Bachelor’s degree in life sciences or equivalent combination of training and experience
• 3+ years of clinical research experience
• 2+ years of site management or clinical project management experience
• Knowledge of GCP/ISO14155 and current industry practices
• Proficiency with MS Office tools including Outlook, Word, Excel, PowerPoint, OneNote, To-Do and SharePoint
• Strong knowledge of CTMS, CDMS and eTMF systems
• Excellent interpersonal, communication and presentation skills
• Ability to travel up to 60% or more during peak periods
• Role may be hired anywhere in the United States and live within 45 minutes of an international airport

Aufgaben

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

Kenntnisse

Site management

Monitoring

Clinical research

Regulatory compliance

CTMS/CDMS

ICH GCP ISO14155

Microsoft Office

Communication skills

Travel willingness

Ausbildung

BS/BA life sciences

MS preferred

Tools

ETMF

CDMS

MS Office Suite

SharePoint

Jobbeschreibung

• 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