Clinical Research Associate II

Clinical Research Associate IIRedwood City, California, United StatesFor 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.ResponsibilitiesSupervises study preparation, site preparation and the in clinic phases directly or through a CRO for assigned studiesEnsures that Good Clinical Practices and Corcept clinical SOPs are met throughout the clinical programActs as liaison with clinical vendors and other functional area team members to meet project goalsCoordinates 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 budgetsProduces RFPs and participates in the evaluation and negotiation of bids from prospective vendorsShares protocol writing with the medical director and biostatistician and ensures that all boilerplate requirements are metDrafts informed consent forms ensuring that they are in agreement with the protocolsParticipates in the development of study related documents including CRFs, study manuals and related documentsCoordinates all study start up activities, potentially with and through the CROParticipates in site management and monitors study sites in the field with the CRO or independently on an as needed basisCollects, reviews and tracks essential trial documentsProvides the clinical team and the program team with information regarding CRO and clinical site performance and recommend remediation when neededParticipates in study management to ensure study project goals are metOther duties as assignedPreferred Education & ExperienceBS / BA (science or health care field) or RN3+ years' experience as a CRA or field monitor at least some of which was in a big pharma or big CRO settingAdditional experience in the pharmaceutical industry is desirablePreferred Skills & ExperienceKnowledge of the clinical trials process, the application of SOPs, and medical terminologyTherapeutic and protocol knowledgeExcellent verbal and written communication skillsKnowledge of GCP regulatory requirementsKnowledge of drug product supply requirementsAbility to handle multiple tasks with competing prioritiesAbility to utilize a wide range of computer applications and toolsThe 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 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.Corcept is an Equal Opportunity Employer