BD is a global medical technology company that is advancing the world of health. www.bd.com
Senior Clinical Research Associate
Location
Rhode Island
Posted
8 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
BD
• Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators) • Acts as the primary liaison between BD and the investigational site • Perform all types of monitoring visits (i.e., on-site, virtual/remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to plan • Conducts source document verification per plan • Routinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and procedures • Site interactions involve prioritization of subject safety including appropriately administered informed consent • Review/report AE/SAEs and protocol deviations per industry and BD standards • Maintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters • Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc • Produce proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards) • Collaborate with the studies cross-functional team members and actively participate in meetings • Assist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc. • Make sure site staff are adequately trained in all project-related requirements and tasks • Support audit activities, as appropriate • Ensure site(s) maintains an acceptable inventory of clinical supplies and associated documentation
Job Requirements
- Bachelor’s Degree or higher in a healthcare or science related field AND 2+ years of relevant clinical research experience is required
- OR - Associate’s Degree or higher in a healthcare or science related field AND 3+ years of relevant clinical research experience is required
- Good Clinical Practices (GCP) certification from an accredited program is required
- Medical device experience is preferred
- Fluent knowledge of spoken and written English language, including medical terminology
- Superior written and verbal communication skills
- Proficiency in presentation preparation and delivery
- Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance
- Previous experience with EDC, CTMS and eTMF systems required
- Understanding of clinical study management processes and systems, including monitoring, investigational product handling, data management, etc.
- Understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPAA
- Ability to work in and promote team cohesiveness in a virtual/remote environment
- Exhibit flexible organizational change approaches with a growth mindset
- Demonstrated ability to prioritize multiple tasks with challenging timelines and results
- Ability to master understanding of the disease state and product(s) under investigation.
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
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