Corcept Therapeutics · 12 hours ago
Clinical Trial Assistant I
Redwood City, CA
Full-time
Hybrid
New Grad, Entry Level
$82K/yr - $97K/yr
0+ years expCorcept Therapeutics is a leader in the research and development of cortisol modulators, dedicated to advancing the treatment of serious diseases. The Clinical Trial Assistant I will support the study team in conducting clinical research projects efficiently and effectively, assisting with various documentation and administrative tasks.
BiotechnologyMedicalPharmaceutical
No H1B
Responsibilities
Assist with the distribution of key study documents such as investigator brochures, protocols, informed consent forms, interim safety reports, and site educational and reference material
Assist with formatting and production of site facing materials
Assist project team with study specific documentation, including filing to the Trial Master File and/or Clinical Trial Management System
Maintain and perform routine reviews of the Trial Master File
Assist the project team with investigator recruitment by obtaining confidentiality agreements, forwarding study synopsis to sites, and distribution of feasibility questionnaires
Assist project team with gathering agenda topics, preparing agenda, scheduling meetings, attend and generate project meeting minutes
Facilitate collection of regulatory documents for initial internal IP and regulatory release
Coordinate collection, tracking, and maintenance of updated site regulatory documentation
Assist in collating materials for investigator, scientific meetings, and conferences, including invitations, agendas, and materials distribution
Track and ship (as needed) study supplies provided by Corcept and study specific vendors
Set up and maintain study tracking tools with the oversight of the manager
Develop working knowledge of company standard operating procedures (SOPs) and FDA regulations related to clinical studies
Provide general administrative support to the Clinical Operations Department
Other duties as assigned by the manager
Qualification
Required
Assist with the distribution of key study documents such as investigator brochures, protocols, informed consent forms, interim safety reports, and site educational and reference material
Assist with formatting and production of site facing materials
Assist project team with study specific documentation, including filing to the Trial Master File and/or Clinical Trial Management System
Maintain and perform routine reviews of the Trial Master File
Assist the project team with investigator recruitment by obtaining confidentiality agreements, forwarding study synopsis to sites, and distribution of feasibility questionnaires
Assist project team with gathering agenda topics, preparing agenda, scheduling meetings, attend and generate project meeting minutes
Facilitate collection of regulatory documents for initial internal IP and regulatory release
Coordinate collection, tracking, and maintenance of updated site regulatory documentation
Assist in collating materials for investigator, scientific meetings, and conferences, including invitations, agendas, and materials distribution
Track and ship (as needed) study supplies provided by Corcept and study specific vendors
Set up and maintain study tracking tools with the oversight of the manager
Develop working knowledge of company standard operating procedures (SOPs) and FDA regulations related to clinical studies
Provide general administrative support to the Clinical Operations Department
Other duties as assigned by the manager
Familiarity with applicable regulatory requirements, Good Clinical Practice/ICH, and Good Documentation Practices
Ability to read and understand scientific literature
Excellent verbal and written communication skills
Strong proficiency in Microsoft Office Suite
Ability to work as part of a multifunctional team
BA/BS or equivalent work experience
0-2 year's experience in pharma related industry
Applicants must be currently authorized to work in the United States on a full-time basis
Company
Corcept Therapeutics
Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$119.09MKey Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M
Leadership Team
Roberto Vieira
President, Oncology
Yuan Xu
Associate Director, Statistical Programming
Recent News
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