Clinical Trial Assistant

Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity. In 2022, we generated revenue of $402 million and net income of $101 million.

We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (“ALS”).  We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (“NASH”) by the end of this year.  Every year, we advance new molecules to the clinic.

Over the next few years, we expect to submit several new drug applications.

The Clinical Trial Assistant will assist the study team in ensuring the most effective and efficient conduct of clinical research projects by providing planning, implementation, and tracking support.

Responsibilities:

• Assist with formatting/production and distribution of key study documents such as investigator brochures, protocols, informed consent forms, interim safety reports, and site educational and reference material
• Assist project team with study specific documentation including filing to the Clinical Trial Management System and Trial Master File
• Maintain Trial Master File by setting up and using tracking tools
• Assist with investigator recruitment by making initial site contact, obtaining confidentiality agreements, forwarding study synopsis to sites and administering feasibility questionnaires
• Assist project team with gathering agenda topics, preparing agenda, scheduling meetings, attend and generate project meeting minutes
• Facilitate submission of regulatory documents to/for a central institutional review board (IRB) and coordinate collection, tracking, and maintenance of updated site regulatory documentation
• Participate in organizing investigator meetings including venue investigation, selection, invitations, agenda and materials distribution
• Track clinical supply inventory at sites and manage the site drug re-supply process
• Set-up and maintain tracking system with oversight of 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

Preferred Skills, Qualifications and Technical Proficiencies:

• 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
• Ability to work as part of a multifunctional team

Preferred Education and Experience:

• BA/BS or equivalent work experience
• 3+ years experience in pharma related industry

The pay range that the Company reasonably expects to pay for this position is $98,000 - $116,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

 Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer