Clinical Research Associate II

Clinical Research Associate II 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

Corcept Therapeutics is hiring for this role on CareerPlace.

Apply on the company website through Corcept Therapeutics.

Imported from employer careers page. Source ref: 259221a0f992.