Clinical Research Associate II
Corcept Therapeutics
9 days ago
On-site
Redwood City, CA
Clinical Research and Development
The Clinical Research Associate (CRA) II monitors clinical study activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols (onsite role).
Responsibilities:
- Supervises study preparation, site preparation, and in-clinic phases directly or through a CRO for assigned studies
- Ensures GCPs and Corcept clinical SOPs are met throughout the clinical program
- Acts as liaison with clinical vendors and other functional team members to meet project goals
- Coordinates cross-functional components of clinical trials (e.g., drug product supplies)
- Participates in preparation and negotiation of clinical trial agreements and study budgets
- Produces RFPs and participates in evaluation/negotiation of bids from prospective vendors
- Shares protocol writing with the medical director and biostatistician; ensures boilerplate requirements are met
- Drafts informed consent forms aligned with the protocols
- Participates in development of study documents (e.g., CRFs, study manuals)
- Coordinates study start-up activities, potentially with/through the CRO
- Participates in site management; monitors study sites in the field with the CRO or independently as needed
- Collects, reviews, and tracks essential trial documents
- Provides input on CRO and site performance and recommends remediation
- Participates in study management to meet project goals
- Other duties as assigned
Preferred Education & Experience:
- BS/BA in science/healthcare or RN
- 3+ years’ experience as a CRA or field monitor (at least 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
- Knowledge of drug product supply requirements
- Ability to handle multiple priorities
- Ability to utilize computer applications/tools
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.
Responsibilities:
- Supervises study preparation, site preparation, and in-clinic phases directly or through a CRO for assigned studies
- Ensures GCPs and Corcept clinical SOPs are met throughout the clinical program
- Acts as liaison with clinical vendors and other functional team members to meet project goals
- Coordinates cross-functional components of clinical trials (e.g., drug product supplies)
- Participates in preparation and negotiation of clinical trial agreements and study budgets
- Produces RFPs and participates in evaluation/negotiation of bids from prospective vendors
- Shares protocol writing with the medical director and biostatistician; ensures boilerplate requirements are met
- Drafts informed consent forms aligned with the protocols
- Participates in development of study documents (e.g., CRFs, study manuals)
- Coordinates study start-up activities, potentially with/through the CRO
- Participates in site management; monitors study sites in the field with the CRO or independently as needed
- Collects, reviews, and tracks essential trial documents
- Provides input on CRO and site performance and recommends remediation
- Participates in study management to meet project goals
- Other duties as assigned
Preferred Education & Experience:
- BS/BA in science/healthcare or RN
- 3+ years’ experience as a CRA or field monitor (at least 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
- Knowledge of drug product supply requirements
- Ability to handle multiple priorities
- Ability to utilize computer applications/tools
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.