• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies. • Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs. • Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments. • Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit. • Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents. • Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial. • Coordinating initial source review and update process. • Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial. • Updating current source documents according to new clinical study protocol amendments. • Activating studies and visits at the appropriate time. • Supporting Quality Control (QC) of source documents before it goes to the users. • Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out. • Maintaining a single tracker for the department to track source document design activities and the status of the activities. • Maintaining version control of all source documents. • Managing daily communication with site staff and other internal departments. • Remaining up to date with all assigned Clinical Study Protocol for study. • Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures. • Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork. • Participating in continuing education activities to maintain current knowledge of source document design and relevant software. • Performing all other duties that may be requested or assigned.

Role Description At Carrum, we live and breathe the mission of transforming the healthcare system to create an unmatched experience for patients. As a senior member of the Care Team, the Senior Clinical Care Navigator serves as the lead architect for the most complex patient journeys and multi-system coordination needs. The SCCN masters the intersection of clinical excellence and operational strategy, managing high-acuity cases while simultaneously refining the workflows that drive care continuity. You’re excited about this opportunity because you will... - Own Complex Care: Have the autonomy to manage advanced cardiology caseloads, guiding patients from diagnosis through recovery and ensuring no one falls through the cracks of the healthcare system. - Represent the Service Line: Serve as a key clinical representative for the Cardiology Service Line, tracking critical case metrics and collaborating with cross-functional partners to support the program's growth. - Drive Operational Success: Take individual ownership of the clinical and operational success of your assigned cases, ensuring patients achieve the best possible health outcomes. - Document Best Practices: Use your technical writing skills to translate clinical workflows into clear, repeatable documentation and standard processes. - Refine Care Models: Influence our care models by identifying operational gaps and providing feedback to help set the standard for navigation workflows. - Bridge Clinical & Business Operations: Act as a critical link between Center of Excellence (CoE) clinical experts and our internal clinical operations teams to ensure business execution aligns with clinical intent. - Caseload Management: Manage a dedicated caseload of cardiology patients; identify eligible candidates and facilitate all necessary referrals for testing and procedural appointments. - Care Path Execution: Participate in the implementation and evaluation of educational materials and clinical care paths to ensure patient adherence to medical plans and behavioral modifications. - Operational Alignment: Work closely with management on daily operations, contributing insights toward short- and long-range planning to improve service delivery and patient satisfaction. - Subject Matter Expertise: Serve as a clinical resource for the care team, providing guidance on cardiac diagnosis management and patient quality-of-life matters. - End-to-End Navigation: Own the seamless delivery of care for your patients, ensuring they experience clear, coordinated, and timely care throughout their journey. - Continuous Improvement: Identify operational bottlenecks and workflow gaps, contributing actionable insights that enhance the overall patient experience. - Change Adaptability: Serve as a stabilizing force within the team as processes, digital tools, and organizational needs evolve. - Cross-Functional Collaboration: Partner across departments to support workflow improvements and ensure clinical execution aligns with patient experience goals. Qualifications - Registered Nurse with a BSN and a proven track record (5+ years) of progressive experience in cardiology. - Technical savvy to collect, report, and present program metrics (via Excel, PowerPoint, etc.) to drive quality improvement and regulatory compliance. - Ability to manage complex workflows, high-impact responsibilities, and advanced patient scenarios. - Commitment to providing the highest level of service through empathy, professionalism, and integrity. - Ability to handle confidential information and adhere to HIPAA requirements. - Comfortable interacting through a variety of tech platforms and can quickly learn new software. Requirements - Bachelor of Science in Nursing (BSN) from an accredited School of Nursing is required. - Minimum of 5+ years of progressive clinical experience in Cardiology is preferred. - Demonstrated ability to lead interdisciplinary teams and manage specialty clinics with minimal supervision. - High level of proficiency in Evidence-Based Practice (EBP) and relationship-based care models. - Current and unrestricted Registered Nurse licensure. - Nice to have: Spanish Speaking preferred. - Nice to have: Board certification in Cardiac-Vascular Nursing (RN-BC) or as a Care Coordination and Transition Management (CCCTM) professional is highly recommended. Benefits - Stock option plan - Flexible schedules and remote work - Chicago and San Francisco offices available - Self-managed vacation days, within reason - Paid parental leave - Health, vision, and dental insurance - 401K retirement plan Company Description We’re a health tech company that brings value-based care to the masses. We help employers deliver a memorable patient experience, immediately lower healthcare costs, and drive better outcomes through the power of technology and human-centered design. Since launching in 2014, we’ve partnered with Fortune 500 employers and top hospitals across the nation. We’ve been recognized by Harvard Business School and featured in TechCrunch, The Los Angeles Times, Washington Post, and Modern Healthcare.

• Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements. • Recruit global study sites and foster relationships with study investigators. • Participate in the process of site and vendor selection, qualification, and activation. • Develop Requests-for-Proposals and assist in vendor selection efforts. • Assist in review and negotiation of vendor contracts and study site clinical trial agreements. • Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging). • Monitor the progress of trials, including enrollment and clinical trial material inventory. • Review monitoring visit reports for completeness and adherence to the annotations. • Assist in packaging/labeling/distribution of clinical trial material. • Monitor and track biological samples for applicable analyses. • Provide progress updates to management and during program team meetings. • Assist in departmental budgeting, including accruals and projections. • Assist in development of protocols, consent forms, IRB/EC materials, and other trial documents. • Assist in development of Clinical SOPs. • Prepare/review/approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, project plans, and monitoring reports. • Assist in electronic case report form design and development. • Assist in IRT design and development. • Participate in data cleaning activities and developing appropriate data outputs. • Understand and help fulfill the needs of other Erasca departments (e.g., Finance, Research). • Provide leadership and mentoring of other Clinical team members. • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

• Responsible for the implementation of clinical trial activities per study protocol. • Works closely with investigative site personnel, CROs, and other study vendors. • Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites. • Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders. • Train CROs, vendors, investigators and study coordinators on study protocol and relevant requirement. • Monitor and track clinical trial progress and provide status update to stakeholders. • Partner with other research and development groups to achieve deliverables. • Mentor junior clinical operations staff and supervise clinical study team. • This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.