South San Francisco, California
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The Position
Purpose:The Genentech Research and EarlyDevelopment (gRED) Clinical Trial Associate (CTA) is responsible for providinglogistical support for one or more early development clinical studies.
Primary Accountabilities and Responsibilities:
Provide logistical support for StudyTeam
• Develop, maintain and manageappropriate study documentation
• Collect, review and approveregulatory documents from clinical sites
• Initiate, maintain and reconcileTrial Master File
• Set up and maintain tracking systemsand tools and report study metrics to support the clinical study
• Coordinate communication of trackinginformation within Study Team and to sites
• Manage and track clinical andnon-clinical supplies
• Manage and track study-specificpayments
• Coordinate investigator meetingplanning in concert with travel planners, including preparing meeting materialsand on-site meeting implementation; may present at investigator meetings
• Develop study related documents incollaboration with the study team
• Assist with vendor management incollaboration with the Senior/Clinical Trial Manager (Functional Managementagreement required)
• Provide coaching and technicalsupport to other CTAs as required
• Serve as a subject matter expert forCTA role on global and gRED task forces, initiatives and working groups
These statements are not intended to bean exhaustive list of all responsibilities, duties, and skills required ofpeople assigned to this job, but are instead intended to describe the generalnature and level of the work. Different levels of responsibilities andaccountabilities may be assigned to take account of the skills capabilities andexperience of the individual.
Who You Are
Minimum:2+ years experience in clinicalresearch
• Bachelors degree or equivalentrequired (scientific or healthcare discipline preferred)
• Working knowledge of internationalregulatory and ICH GCP guidelines
Experience, Skills, Knowledge:
Performs job duties independently withminimal supervision and guidance
• Self-motivated and displaysinitiative
• Highly effective verbal and writtencommunication skills in English
• Effectively collaborates with teammembers
• Proven organizational skillsdemonstrated by the ability to understand and prioritize instructions anddeliver on time
• Experience using computerapplications including spreadsheets, email, word-processing software &web-based systems
• Attention to details
Other (e.g. Travel):
Ability to travel (includinginternationally) and work across cultures.
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
0 comments:
Post a Comment