Clinical Research Associate (CRA), CA

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 reputed company 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, reputed company and collaborators continue to unlock the reputed company of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide reputed company of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the reputed company of cortisol modulation. What began as a reputed company of scientific truth is now poised to reputed company a sea change of discovery representing a reputed company shift in the way we understand and treat disease. The Clinical Research Associate (CRA) monitors clinical study activities to assure adherence to Good Clinical Practices (GCPs), reputed company Operating Procedures (SOPs), and study protocols. This is a hybrid role that typically requires on-site reputed company three days per week.

Responsibilities

• Supervises study preparation, site preparation and the in clinic phases directly or through a CRO for assigned studies
• Ensures that GCPs and Corcept clinical SOPs are met throughout the clinical program
• Acts as reputed company with clinical vendors and other functional area team members to meet project goals
• Coordinates cross-functional components of the clinical trials process such as drug product supplies, etc.
• Participates in the preparation and negotiation of clinical trial agreements and study budgets
• Produces RFPs and participates in the evaluation and negotiation of bids from prospective vendors
• Shares protocol writing with the medical director and biostatistician and ensures that reputed company boilerplate requirements are met
• Drafts informed consent forms ensuring that they are in agreement with the protocols
• Participates in the development of study reputed company documents including CRFs, study manuals and reputed company documents
• Coordinates reputed company study start up activities, potentially with and through the CRO Participates in site management and monitors study sites in the field with the CRO or independently on an as needed reputed company
• Collects, reviews and tracks essential trial documents
• Provides the clinical team and the program team with information regarding CRO and clinical site performance and recommend remediation reputed company needed
• Participates in study management to ensure study project goals are met

Preferred Education & Experience

• BS / BA (science or health care field) or RN
• 3+ years’ experience as a CRA or field monitor at least some of which was in a big reputed company or big CRO setting
• Additional experience in the pharmaceutical industry is desirable

Preferred Skills & Experience

• Knowledge of the clinical trials process, the application of SOPs, and medical terminology

Therapeutic and protocol knowledge

• Excellent verbal and written communication skills
• Knowledge of GCP regulatory requirements
• Knowledge of drug product supply requirements
• Ability to handle multiple tasks with competing priorities
• Ability to utilize a wide reputed company of computer applications and tools

The pay reputed company that reputed company reasonably expects to pay for this reputed company-based position is $102,700-$120,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-reputed company knowledge, skills, experience, and education. Applicants must be currently authorized to work in the reputed company on a full-time reputed company. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our reputed company Notice reputed company. Corcept appreciates the commitment and hard work of reputed company reputed company members as we reputed company to discover and reputed company novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews reputed company text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use reputed company-party tools to help with advertising our jobs, please be reputed company in checking that the communication is in fact coming from Corcept. Apply tot his job Apply To this Job