[Hiring] Clinical Research Associate II @BD

Role Description

Independently Provide Site Management & Monitoring support for BDPI clinical studies to enable successful completion of study objectives and deliverables.

• Ensure quality and compliance for assigned clinical studies and study activities performed at assigned clinical sites.
• Conduct on-site or remote clinical site monitoring activities for assigned clinical sites.
• Serve as a product, procedure and clinical study protocol resource for BD stakeholders, Investigators, and study site personnel.
• Develop and maintain strong relationships as the primary site contact.
• Develop and manage study-specific tracking reports to detail clinical study progress.
• Perform study and/or site-level audits of the Trial Master File (TMF).
• Assist with study and site-level management of the Clinical Trial Management System (CTMS).
• Develop and/or complete study-specific clinical documents as needed.
• Review and provide input on the development of other essential clinical study documents.
• Proactively examine ways to enhance overall clinical study performance.
• Communicate BD product complaints and other events/issues to BD stakeholders.
• Participate in, support and/or lead study-specific meetings.
• Support Clinical Project Management with other administrative tasks.
• Provide critical thinking and support for issue escalation related to site management & monitoring.
• Provide support for internal or external audits/inspections.
• Support continuous improvement activities/initiatives.
• Mentor Site Management & Monitoring personnel and conduct monitoring evaluations.

Qualifications

• 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.

Requirements

• Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (ICH GCP/ISO14155).
• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.).
• Strong knowledge of clinical study processes and systems (eTMF, CTMS and CDMS).
• Strong interpersonal and communication/presentation (oral and written) skills.
• Strong organizational skills, attention to detail, critical thinking and analytical skills.
• Able to manage and delegate multiple tasks and prioritize importance of tasks/projects.
• Ability to travel up to 60% (or more during peak times).

Benefits

• On-site collaboration fostering creativity and innovation.
• Minimum of 4 days of in-office presence per week for most roles.
• Flexibility and work-life balance recognized.