Sr. Clinical research associate (RE-12451783) San Carlos, California

Salary: negotiable

Position and Primary Responsibilities: 

  • Partner with clinical staff and CROs for planning/coordination of Investigator Meetings, CRF development, generation of study tools, regulatory document collection, patient recruitment programs, review of monitoring and data management plans
  • Partner with members of Clinical, Regulatory and Manufacturing Departments to meet clinical milestones/timelines
  • Revise/amend study protocols and consent forms
  • Day-to-day management of vendors
  • Conduct site qualification, initiation, monitoring and close out visits as well as co-monitoring visits with regional CRAs as needed
  • Conduct initiation, routine monitoring and closeout visits for PTI studies managed internally
  • Communicate with sites and regional CRAs to ensure proper study conduct
  • Review regional CRA monitoring reports
  • Proactively identify issues and propose appropriate solutions
  • Communicate status of clinical studies to Clinical Operations Senior Mgmt
  • Track costs for individual studies and review monthly invoices
  • Manage drug supply activities
  • Oversee safety reporting with medical monitor
  • Assist in the development/implementation of departmental procedures and SOPs 

 Background, Education and Experience Required: 

  • 5+ years of clinical research experience
  • 1+ years of clinical project management experience
  • Bachelor’s degree in health sciences
  • In depth knowledge of ICH/GCP and drug development process

 Personal Characteristics: 

  • Excellent communication skills (oral, written, listening)
  • Honesty, integrity, hard-working and committed to achieving difficult goals
  • Effective interactions with management
  • Proactive and independent
  • Capable of working with multiple contractors, academic and investigative sites to manage and focus priorities
  • Positive, outgoing and enthusiastic personality