Senior Clinical Research Associate

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
• 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

Corcept is an Equal Opportunity Employer