Clinical Research Associate II

Clinical Research Associate (CRA) II (Onsite)

Responsibilities:
- Supervise study preparation, site preparation, and in-clinic phases directly or through a CRO for assigned studies
- Ensure GCPs and Corcept clinical SOPs are met throughout the clinical program
- Liaise with clinical vendors and other functional teams to meet project goals
- Coordinate cross-functional trial components (e.g., drug product supplies)
- Participate in preparation and negotiation of clinical trial agreements and study budgets
- Produce RFPs and evaluate/negotiates bids from prospective vendors
- Share protocol writing with the medical director and biostatistician and ensure boilerplate requirements are met
- Draft informed consent forms aligned with protocols
- Participate in development of study documents (CRFs, study manuals, and related documents)
- Coordinate study start-up activities, potentially with/through the CRO
- Participate in site management; monitor sites in the field with the CRO or independently as needed
- Collect, review, and track essential trial documents
- Provide information on CRO/site performance and recommend remediation
- Participate in study management to ensure project goals are met
- Other duties as assigned

Preferred Education & Experience:
- BS/BA (science or healthcare) or RN
- 3+ years as a CRA or field monitor (some in big pharma or big CRO)
- Additional pharmaceutical industry experience desirable

Preferred Skills & Experience:
- Knowledge of clinical trials process, SOPs, and medical terminology
- Therapeutic and protocol knowledge
- Excellent verbal and written communication skills
- Knowledge of GCP regulatory requirements and drug product supply requirements
- Ability to handle multiple priorities
- Ability to use a wide range of computer applications/tools

Application Instructions:
- Applicants must be authorized to work in the United States on a full-time basis.