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.

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
• 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

Qualifications

• 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

Education

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