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 $149,000-$170,000; 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.

We are seeking a dynamic and strategic professional to join our organization as a Sourcing Manager within Clinical Research & Development. In this role, you will lead the development and execution of sourcing strategies, manage a diverse supplier portfolio, and drive continuous improvement across procurement processes. You will work cross-functionally to enhance supplier performance, manage risk, and deliver cost-effective, high-quality solutions aligned with business goals. This role supports Clinical Research & Development teams by leading sourcing activities and vendor negotiations for Corcept’s clinical trials. This position requires strong analytical skills, excellent communication, strategic thinking, and a proven ability to build and maintain effective supplier and stakeholder relationships.

Key Responsibilities:

• Develop and implement sourcing strategies to achieve procurement goals and long-term business objectives
• Lead the creation and finalization of Site Clinical Trial Agreements (CTAs), CRO agreements, and Investigator Grant budgets
• Develop global contracting strategies, including site-specific timelines and templates to streamline trial start-up
• Manage supplier relationships to ensure high-quality, cost-effective products and services
• Oversee supplier performance through evaluations, KPIs, and continuous improvement initiatives
• Conduct market research and financial analysis to inform sourcing decisions and negotiate contracts
• Optimize supply chain performance and drive cost-saving initiatives across assigned categories
• Identify, assess, and mitigate supply-related risks
• Lead RFP processes and validate suppliers based on business and quality requirements
• Collaborate with internal teams to align strategies and resolve issues
• Investigate supplier-related issues or complaints and ensure corrective actions are completed
• Provide regular reporting and insights to senior leadership on sourcing performance and opportunities
• Contribute to procurement policy development, process improvements, and operational efficiencies
• Ensure adherence to contract terms, regulatory requirements, and company policies
• Stay current on industry trends, supply market intelligence, and best practices

Qualifications:

• Bachelor’s degree in a related field or equivalent work experience
• Minimum of 5 years of experience in sourcing, procurement, or supply chain management within the biotechnology or pharmaceutical clinical environment, with a strong understanding of the drug development process
• Experience in leading and supporting sourcing initiatives (rapid sourcing, targeted negotiations, supplier relationship management, outsourcing), including successfully negotiating economic terms with CROs and vendors
• Strong analytical, financial, and problem-solving skills
• Excellent verbal and written communication abilities; capable of engaging stakeholders at all levels
• Experience managing supplier portfolios and executing sourcing strategies
• Results-oriented, strategic thinker with the ability to lead complex projects
• Ability to work cross-functionally and influence decisions in a matrixed environment
• Experience negotiating contracts and resolving supplier disputes
• Ability to travel up to 10% (if applicable)
• Commitment to fostering diversity, equity, and inclusion within the supply base and workplace

The pay range that the Company reasonably expects to pay for this headquarters-based position is $150,700 – $177,300; 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.

Responsibilities:

• Design and implement Phase I to III clinical studies
• Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Provide scientific oversight for Company operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs
• Act as a clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Act to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Play a key role in the analysis, interpretation and delivery of high-quality clinical data
• Interact with principal investigators and opinion leaders to facilitate clinical trials research
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
• Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
• Develop and give internal and external presentations as subject matter expert for the therapeutic area
• Participate in the development and review of publications
• Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrate strong clinical and scientific knowledge
• Is an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
• Feel comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Preferred Education and Experience:

• MD, board-certified (or eligible)
• Expertise in Oncology
• A strong track record of scientific activity, demonstrated by publications in top tier journals
• At least 6+ years of relevant clinical development experience
• Relevant basic and/or clinical research experience in academic settings is viewed favorably

The pay range that the Company reasonably expects to pay for this headquarters-based position is $298,000-$350,600; 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.

The Clinical Trial Manager (CTM) will independently manage all clinical aspects of a medium to large clinical study or up to two smaller clinical studies.  This role will work closely with cross-functional teams, 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 that typically requires on-site presence three days per week.

Responsibilities: 

• Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate and department program goals
• May serve as a Study Lead to the multifunctional team to ensure clinical study/studies activities, including study start-up, enrollment, maintenance, and closeout, are executed per timelines and budget.
• Oversees aspects of study management and vendors to ensure high quality of data
• Providing Clinical Research Associates with project-specific training, guidance, and oversight, assigning deliverables and having regular meetings with them
• Develops clinical trial protocol synopsis, protocols, amendments as directed by the Clinical Development team and while working with Medical Writing
• Develops critical study documents such as informed consent form templates, site management, and monitoring tools
• Evaluates study designs from an operations perspective, and considers site implementation tactics to suggest feasible solutions and contribute to overall program design and execution
• Develops study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budget
• Responsible for tracking and managing study execution to resources and goals
• Facilitating the CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions.  Includes review of Scope of Work, budgets, and negotiating contracts through execution
• Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to appropriate internal stakeholders
• Creates a process for developing distribution, reviews, and tracking essential trial documents and/or oversees CRO or CRA responsibility for essential documents
• Collaborates with team CRAs to ensure essential trial documents are provided to Regulatory for submission to the FDA and other regulatory agencies for IND Updates and Amendments
• Develops and ensures compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes
• May conduct and/or attend PSVs, SIVs, IMVs, and COVs
• Partners in the development of the case report form (CRF) design process including content, form layout, and edit check review
• Liaison with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trial
• Ensures CRA(s) maintain a complete and updated regulatory file for each assigned site
• Manages oversight of Investigational Product (IP) accountability and ensures adequate site supply
• Manages safety reporting to sites and regulatory agencies
• Procures and manages contracts with CROs, study vendors, and investigative sites
• Manages and/or provides oversight of CROs, independent field monitors, and other clinical vendors
• Ensures monitoring trip reports are reviewed and track resolution of all action items on time, per the Monitoring Plan or Corcept SOPs
• Co-monitors at investigative sites to evaluate study site and field monitor performance
• Manages, either directly or through supervised delegation, 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 tracks questions/processes for best practices and consistency
• May help audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations
• Exercises sound judgment to resolve or, as appropriate seek expert input on protocol and drug questions, safety, regulatory, and legal questions. Ensures resolution is tracked and consistently messaged to all team members and clinical sites
• Contribute to the SOP review process and other Clinical Operations Initiatives, as necessary
• Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coach junior staff on the same
• Ensures Trial Master File is maintained throughout the study
• Practices professionalism and integrity in all actions and relationships with Corcept management, supervisors, team members, direct reports, and vendors. Exhibits and models leadership behavior through communication and appropriate temperament. Ability to have difficult/crucial conversations with tact. Demonstrates ability to foster teamwork, cooperation, self-mastery, and flexibility to get the work done.  Maintains composure under difficult circumstances
• Travel may be up to 30% occasionally
• This position may supervise the following positions: Clinical Operations Consultants and Clinical Research Associates

Preferred Education and Experience: 

• Relevant BS / BA degree or nursing degree
• 6+ years’ experience as a CRA or field monitor in a biotech, pharmaceutical, or CRO company
• Study-related management experience

Preferred Skills, Qualifications, or Technical Proficiencies: 

• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Excellent verbal and written communication
• Able to collaborate effectively with the study team, cross-functional team members, and external partners
• Knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, the application of SOPs, and medical terminology
• Strong interpersonal, problem-solving, and organizational skills
• Self-motivated and able to motivate others
• Sound judgment and discretion
• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Ability to read and understand scientific literature
• Strong organization and time management skills
• 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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $156,600-$184,300; 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.

The Senior Clinical Trial Manager (Sr. CTM) will play a key role in shaping and scaling Corcept’s clinical operations processes and SOP framework. This position may also independently manage operational aspects of clinical study. This leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol requirements to ensure study deliverables, milestones, and objectives are met within timelines and budget. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Proactively identify gaps in workflows and documentation, and designing scalable, inspection-ready SOPs and processes that enable high-quality study execution
• Author updates, and continuously improve SOPs, work instructions, templates, and forms to ensure they are lean, practical, and aligned with ICH-GCP E6 (R2/R3) standards
• Evaluate the downstream impact of SOP and process changes on ongoing trials, vendor contracts, and clinical systems (e.g., CTMS), ensuring seamless adoption without disrupting active programs
• Facilitate cross-functional SOP review and working groups
• Contribute to SOP governance, inspection readiness, and continuous improvement initiatives that strengthen Corcept’s clinical operations infrastructure
• Execute assigned clinical protocol with high quality according to Corcept SOPs, ICH/GCP, and corporate and departmental program goals
• Serve as a study lead to the multifunctional team to ensure clinical study/studies activities including study start-up, enrollment, maintenance, and close-out are executed per timeline and budget
• Work with Clinical Development and/or Medical Writing to generate clinical trial protocol synopsis, protocols, and protocol amendments
• Facilitate the CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions. This includes review of cope of ork, budgets, and negotiating contracts through execution
• Procure and manage contracts with CROs, study vendors, and investigative sites
• Develop critical study documents, including informed consent form templates, various management plans, and study trackers
• Develop study timelines and budgets per the corporate and departmental goals and continuously strive to ensure timelines are deliverables are met within budget
• Develop, distribute, review, and track essential trial documents and/or oversee CRO responsibility for essential documents
• Provide Regulatory with Site Essential Regulatory Documents for submission to the FDA and other regulatory agencies
• Manage or provide oversight of CROs, independent field monitors, and other clinical vendors
• Ensure monitoring trip reports are reviewed and track resolution of all action items and protocol deviations
• Manage, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, data quality, and central records quality
• Audit clinical data reports for accuracy, safety, and/or efficacy trends and prepare related presentations
• Ensure the Trial Master File is maintained throughout the study in accordance with regulatory and company requirements

Preferred Education and Experience:

• Relevant BS / BA degree or nursing degree
• 8+ years' experience in a biotech or pharmaceutical company, leading cross-functional clinical activities
• Management experience including outsourcing to Contract Research Organization (CRO)

Preferred Skills, Qualifications, or Technical Proficiencies:

• Knowledge of US and GCP/ICH regulations
• Understanding of the clinical trials process, the application of SOPs, and medical terminology
• Ability to read and understand scientific literature
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools

The pay range that the Company reasonably expects to pay for this headquarters-based position is $170,500-$200,700; 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.