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Senior Clinical Research Associate
BDSenior Clinical Research Associate responsible for managing and monitoring clinical studies for BD Peripheral Intervention. Ensuring compliance with protocols and establishing relationships with site personnel.
About the role
Key responsibilities & impact- Provide Site Management & Monitoring support for BDPI clinical studies to enable successful completion of study objectives and deliverables.
- Conduct on-site or remote clinical site monitoring activities for assigned clinical sites to evaluate sites for qualification or activation, review informed consent forms, review subject data for accuracy, issue and address data queries.
- Develop and maintain strong relationships with investigational site staff, hospital personnel, and cross-functional study teams to support study deliverables.
- Perform study and/or site-level audits of the Trial Master File (TMF) for accuracy, that files are current, complete and audit-ready.
Requirements
What you’ll need- Bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
- 5+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
- 4+ years of experience with site management & monitoring or managing clinical projects
- Strong working knowledge of domestic and international clinical research regulations and guidelines
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
- Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
- Strong organizational skills, attention to detail, effective judgment and analytical skills
- Ability to travel up to 60% (or more during peak times)
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchsite managementmonitoringstudy auditsdata accuracyinformed consent reviewclinical study processeseTMFCTMSCDMS
Soft Skills
organizational skillsattention to detaileffective judgmentanalytical skillsrelationship building