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 andEarly Development (gRED) Clinical Trial Associate (CTA) is responsible forproviding logistical support for one or more early development clinicalstudies.
Primary Accountabilities andResponsibilities:
• _Providelogistical support for Study Team
• _Develop,maintain and manage appropriate study documentation
• _Collect,review and approve regulatory documents from clinical sites
•_Initiate, maintain and reconcile Trial Master File
• _Set upand maintain tracking systems and tools and report study metrics to support theclinical study
•_Coordinate communication of tracking information within Study Team and to thesites
• _Manageand track clinical and non-clinical supplies
• _Manageand track study-specific payments
•_Coordinate investigator meeting planning in concert with travel planners,including preparing meeting materials and on-site meeting implementation; maypresent at investigator meetings
• _Developstudy related documents in collaboration with the study team
• _Mayprovide coaching and support to other CTAs
• _Mayserve as a subject matter expert for CTA role on global and gRED task forces,initiatives and working groups
These statements are notintended to be an exhaustive list of all responsibilities, duties, and skillsrequired of people assigned to this job, but are instead intended to describethe general nature and level of the work. Different levels of responsibilitiesand accountabilities may be assigned to take account of the skills capabilitiesand experience of the individual
Who You Are
Minimum:•_Bachelors degree or equivalent required (scientific or healthcare discipline preferred)
•_Experience in clinical research or healthcare related industry
• _Workingknowledge of international regulatory and ICH GCP guidelines
Experience, Skills, Knowledge:
• _Performsjob duties with supervision and guidance
• _Self-motivatedand displays initiative
• _Highlyeffective verbal and written communication 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 totravel (including internationally) 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.
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