Corcept Therapeutics
Senior Clinical Research Associate
Redwood City, California, United States · Senior · Full-time
Work authorization required$149k-$170kDetected 1 day ago
GCPNegotiationClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationProblem SolvingTime ManagementPublic SpeakingOrganizational SkillsMicrosoft Office
About the role
- For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
- Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists.
- With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Responsibilities
- Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately
- Participates in the review of study designs from an operations perspective, and site implementation tactics
- May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection
- Supports Study Lead in the development of study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budget
- Develops study processes in support of the protocol, develops workflow and resource plans to achieve interim goals
- Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to the Study Lead
- Participates in the development of critical study documents such as informed consent form templates, site management, and monitoring tools
- Participates in the development, distribution, review, and tracking of essential trial documents
- Ensures essential documents are submitted to Regulatory for IND Updates and Amendments per the recommended timelines of the Study Lead
- Develops study processes in support of the protocol, develops workflow and resource plans to achieve interim goals; modifies according to study progress
Requirements
- Experience in the pharmaceutical industry
- Excellent knowledge of US and GCP/ICH regulations
- Attention to detail and ability to prioritize tasks to meet critical deadlines
- Ability to read and understand scientific literature
- Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools
- BA/BS degree in a relevant field, nursing degree, or equivalent experience
- 4+ years of experience working in clinical research for a Sponsor company, CRA/field monitor, or CRO setting
- Technical knowledge and experience managing most aspects of clinical studies
- Understanding of the clinical trials process, the application of SOPs, and medical terminology
- Interpersonal, problem-solving, and organizational skills
- Self-motivated and able to motivate others
- Excellent verbal and written communication
- Organization and time management
- Ability to develop and deliver compelling and concise presentations
- Able to work effectively on project teams and independently
Skills
- https://www.corcept.com/
- Corcept is an Equal Opportunity Employer
Compensation
- The pay range that the Company reasonably expects to pay for this headquarters-based position is $149,000-$170,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge
Benefits
- Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to create protocol amendments as needed
- Participates in the evaluation of clinical study reports for accuracy, safety, and/or efficacy trends; as necessary for medical monitor review and/or IDMC meetings
Visa & Work Authorization
- Applicants must be currently authorized to work in the United States on a full-time basis.
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