Research Associate contributing to NIH - funded studies in Dr. Christina Dyar's lab. Managing operations and participant communications, while contributing to manuscripts and presentations.
About the role
- Senior Clinical Research Associate managing clinical studies at BD Biosciences ensuring compliance with regulations and quality. Leading site interactions and mentoring junior team members.
Responsibilities
- Manage day-to-day activities of clinical studies from initiation through close-out
- Ensure compliance with applicable regulations, Good Clinical Practice, company standards and procedures
- Plan and conduct monitoring activities and visits
- Ensure data quality, participant protection of privacy, safety, and compliance with current regulations
- Provide leadership and mentoring within the clinical research team
- Handle site interactions, site training, regulatory document collection, enrollment tracking
- Ensure accuracy, completeness, and verifiable documentation
Requirements
- BS in healthcare or science related discipline
- 5+ years’ experience as Clinical Research Associate directly involved with site monitoring
- Preferably 2+ years of experience with medical devices and/or diagnostic studies
- Professional certification through one or more relevant associations is desirable (e.g., ACRP, SOCRA, RAPS)
- Working knowledge of ICH Good Clinical Practices
- Strong working knowledge of Good Clinical Practices (GCP), local regulations, relevant ISO standards and current industry practices related to the conduct of clinical trials and applicable local and regional regulations
- Previous experience with EDC, CTMS, and eTMF systems required
Benefits
- Health insurance
- Professional development opportunities
- Paid time off
- Remote work options
- Flexible working arrangements
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