Clinical Research Associate (CRA)
About The Position
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Clinical Research Associate (CRA) monitors clinical study activities to assure 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.
Requirements
- 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
- 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
- Applicants must be currently authorized to work in the United States on a full-time basis.
Nice To Haves
- Additional experience in the pharmaceutical industry is desirable
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
