Sr. Clinical Research Associate Anacor Pharmaceuticals, Inc.
THIS JOB HAS EXPIRED Job Summary
The Sr. Clinical Research Associate (Sr. CRA) will be responsible for clinical research activities for new product development. The primary functions of this position are clinical study planning, monitoring, and managing clinical trial timelines. The Sr. CRA will contribute to the planning and coordination of the clinical trials conduct; and ensure adherence to GCP and other applicable guidelines and regulations. In addition, the Sr. CRA will work with the other members of the clinical department, as directed, to develop systems and procedures to ensure uniform operation of projects in the department.
Act independently and with limited supervision
Contribute to the creation and management of project timelines
Assist in the preparation of study protocols, Investigator Brochures, and Case Report Forms
Prepare IRB submissions and other study-related documents in accordance with established processes and procedures
Provide management of CROs and vendors to ensure adherence to study scope, budget, and timelines
Prepare clinical monitoring plans and site monitoring activities, including pre-study training both at clinical sites and the Investigators? Meeting
Establish systems for tracking of various activities during clinical trials, e.g., tracking of clinical data, query resolution, regulatory documents, etc.
Review monitoring reports
Create and update study dashboard
Organize and coordinate Investigators? Meetings
Provide regular reports to the management team
Participate in other research-related activities as assigned
Bachelor?s degree in a science discipline is required. Advanced degree preferred.
4+ years of relevant pharmaceutical industry experience is required with 1+ years of vendor management.
Demonstrated knowledge of the drug development process and clinical research is required.
Experience in clinical trials in multiple geographies.
Experience in infectious diseases or dermatology is a plus.
Experience with electronic data capture is a plus.
Experience in field monitoring is a plus.
In-depth knowledge of regulatory requirements and ICH GCP and 21 CFR guidelines.
Demonstrated success in supporting clinical project management.
Ability to develop and administer budgets, timelines, and trial-specific performance metrics is a plus.
Excellent written and verbal communication skills with attention to detail.
Excellent organizational skills.
Demonstrated skills in creative problem-solving, critical thinking, team play, and leadership.
Experience working successfully in matrix/team environment is a plus.
In-depth knowledge and experience with MS Project is required.
Travel may be required.
Knowledge of Spanish is a plus.
||Palo Alto, CA |
THIS JOB HAS EXPIRED