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Miles
Km80.5

Senior Clinical Research Associate

Pharmacyclics, Inc.

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Location: Sunnyvale, CA Posted Date: 4/10/2013 Position Type: Full time Job Code: 24-HC-8 Required Education: High school or equivalent Areas of Expertise Desired: Clinical Research
Oncology
Operations

Description

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.



Key Accountabilities/Core Job Responsibilities:
•Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
•Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
•Develop study budget and timelines
•Prepare regulatory documents and submissions
•Execute project specific training for internal and external staff
•Maintain Trial Master File
•Manage Investigational Product (IP)
•Manage safety reporting
•Procure and manage contracts with CROs, study vendors and investigative sites
•Provide oversight of CROs, independent field monitors and other clinical vendors
•Review monitoring trip reports and track resolution of all action items
•Co-monitor at investigative sites to evaluate study site and field monitor performance
•Collaborate with medical experts, clinical study sites, and clinical study vendors
•Performs  in-house review of clinical database listings for completeness and accuracy
•Develops clinical study reports

Requirements

Excellent verbal and written communication skills
•Attention to detail
•Able to organize, manage and set priorities for multiple tasks
•Strong leadership skills, self-motivated, adaptable to a dynamic environment
•Able to collaborate effectively with the study team, cross-functional team members, and external partners
•Knowledge of ICH/GCP and FDA regulations
•Proficiency in MS Word, Excel and Powerpoint
•Able and willing to travel approximately 25-30%  

Experience:
•6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience)  
•Experience in oncology preferred
•Experience in global trials preferred
•Experience with Electronic Data Capture systems preferred
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