Clinical Research Associate; CRA

Role Summary

The Clinical Research Associate (CRA) monitors clinical study activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols. This is a hybrid role that typically requires on-site presence three days per week.

• 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
• 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

• 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
• 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

• BS / BA (science or health care field) or RN