Clinical Research Associate II

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. The Clinical Research Associate (CRA) II monitors clinical study activities to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. This is an onsite role. 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 liaison 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 all boilerplate requirements are met Drafts informed consent forms ensuring that they are in agreement with the protocols Participates in the development of study related documents including CRFs, study manuals and related documents Coordinates all 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 basis 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 when needed Participates in study management to ensure study project goals are met Other duties as assigned 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 pharma 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 range of computer applications and tools The pay range that the Company reasonably expects to pay for this headquarters-based position is $129,400 – $152,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. Corcept is an Equal Opportunity Employer. #J-18808-Ljbffr