Senior Clinical Research Associate – Sr Cra

The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO (when applicable) to ensure compliance with protocol and the overall clinical objective. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

• Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to Corcept’s SOPs, ICH/GCP, and corporate and departmental program goals
• 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 protocol development, tracking changes for future protocol amendments, and works with medical writing to create protocol amendments as needed
• Oversees some aspects of study management and vendors to ensure high quality of data
• Works with the in-house CTA to ensure the meeting agendas and meeting minutes are created, tracked, distributed, filed, and are accurate
• 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; modifies according to study progress
• 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
• Participates in the review and negotiation of site budgets and contracts
• Participates in the recruitment of potential Investigators suitable for a particular protocol
• Conducts sponsor oversight visits and may conduct site qualification visits and site initiation visits
• Participates in the development of and ensures compliance with the clinical monitoring plan; co-monitors as needed for staff training and quality assurance (QA) purposes
• Contributes to the case report form (CRF) design process including content, form layout, and edit check review
• Maintains a complete and updated regulatory file for each assigned site
• Supports aspects of study management to ensure high quality of data
• Liaises with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trial. May review site-specific accountability logs to ensure accuracy and report findings to Study Lead
• Supports other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Serves as in-house contact for protocol-related process questions and reports in FAQs
• 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
• Exercises sound judgment to resolve or, as appropriate seek expert input on protocol and drug questions, safety, regulatory, and legal questions
• Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coaches junior staff
• Contributes to the SOP review process and/or other Clinical Operations Initiatives
• Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF audits
• Maintains a complete and updated regulatory file for each assigned site
• Practices professionalism and integrity in all actions and relationships with Corcept management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done
• Travel may be up to 30% occasionally

Preferred Skills, Qualifications and Technical Proficiencies:

• Technical knowledge and experience managing most aspects of clinical studies
• Experience in the pharmaceutical industry
• Excellent knowledge of US and GCP/ICH regulations
• 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
• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Ability to read and understand scientific literature
• 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
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools

Preferred Education and Experience:

• 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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $145,000 - $178,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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