Note: The job is a remote job and is open to candidates in USA. BD is one of the largest global medical technology companies in the world. The Senior Clinical Research Associate will be responsible for building relationships with internal partners and site staff, acting as a liaison between BD and investigational sites, and performing various monitoring visits to ensure compliance with regulations.
Responsibilities
- 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
Skills
- Bachelor's Degree or higher in a healthcare or science related field AND 2+ years of relevant clinical research experience is required
- 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
- 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
- Medical device experience is preferred
Company Overview
Company H1B Sponsorship