Sr. Clinical Research Associate
Redwood City, CA
Privately held, clinical-stage biopharmaceutical company developing a potentially best-in-class MDM2 inhibitor. We have brought together scientists and clinicians with a deep understanding of hematology and oncology and an experienced leadership team.
Together, we’ re building an exciting biotechnology company with a culture defined by caring, ambition, dedication and teamwork!
Sr. Clinical Research Associate (Sr. CRA) will provide appropriate sponsor oversight of sites and conduct clinical research activities according to SOPs and applicable regulations and guidelines. The Sr. CRA will work in a fast-paced environment and proactively communicate with investigators, colleagues, and vendors to ensure clinical quality and compliance in the conduct of clinical trials.
• Support activities within various phases of clinical studies (i.e., study planning, site qualification, and investigator selection, monitoring, closeout, etc.)
• Support the study team through the development of clinical study plans, presentations, study documents (review and approval of informed consent forms (ICFs), site-facing documents and tracking tools, review and tracking of monitoring reports, sample tracking, and other activities as needed
• Co-monitor with CRO CRAs to develop site relationships and ensure training and oversight of the CRO
• Drive site performance and engagement through regular communications and by setting clear expectations, providing feedback, and developing action plans for remediation when needed
• Build and maintain strong relationships with investigators and staff
• Assure compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and GCP guidelines, and Company and SOPs
• Degree in sciences/health care field, nursing degree or equivalent combined education and experience
• 5+ years’ experience as a Clinical Research Associate (CRA) required
• Certificate in Clinical Research or Certified Clinical Research Associate (CCRA) credentials preferred
• Domestic and international travel up to 25%