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A South San Francisco based pharmaceutical company is looking for a Contract Senior CTA to join their growing clinical team.
Job Responsibility:
Provide key support to the clinical study team to support the planning, implementation, and completion of in house and outsourced studies
Work with investigative sites and vendors to provide support
Review and process clinical study related documents including Clinical Visit summaries, protocols, FDA 1572s, lab certifications, IRB approvals, and more
Responsible for eTMF
Maintain and update Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, and more
Prepare agendas and take comprehensive minutes for meetings
Study level tracking (including monitor visit tracking, sample tracking, study related supplies)
Help prepare materials for investigator meetings, monitor workshops, and study manuals
Ensure completed documents are provided to Regulatory Affairs group
Review clinical data in the database, data listings, and reports
Update and maintain public clinical trial listings
Assist with clinical trial insurance policies
Requirements:
Minimum Bachelor’s degree in a relevant scientific discipline
Minimum 2 years of pharma or biotech industry experience within clinical trials
eTMF experience
Applicants must be currently residing in South San Francisco