Clinical Research Associate II

Stellenbeschreibung:

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.