Clinical Trial Assistant I
About The Position
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Clinical Trial Assistant I will support the study team in ensuring the most effective and efficient conduct of clinical research projects. This is a hybrid role typically requiring on-site presence at least 3 days per week.
Requirements
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
