CRA II - Sponsor Dedicated (Home-Based - Target Locations: VA/NC/SC/GA) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $70,100.00 - $126,100.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Job Description General Summary: The Clinical Scientist Principal will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will work on cross-functional study teams on design, execution, and monitoring of clinical trials, as well as data interpretation and communication. This role will also serve as a point of contact for investigators in day-to-day clinical study needs. Key Duties and Responsibilities: - Works with cross-functional team with oversight by the Medical Lead to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities. - Conducts medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. - Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. - Analyzes and synthesizes information to assess issues relating to protocol conduct and/or individual subject safety. - Provides clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports. - Develops protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead. - Collaborates with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations. - Represents Vertex to outside personnel in the development of clinical protocols and study conduct - Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors. - Leads literature reviews as needed. - Prepares scientific material for conference presentations or publications. Knowledge and Skills: - In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy); proficient knowledge of biostatistics, GCP, and regulatory requirements for clinical studies. - Ability to make independent, timely and appropriate decisions. - Strong oral and written communication skills to explain difficult information and solid computer/analytical skills. - Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate. - High level of organizational and project management skills. - Flexibility to accommodate changes in team and project needs. - Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy. Education and Experience: - Bachelor's degree in the Life sciences - Typically requires 6 years of experience in clinical or pre-clinical research in the pharmaceutical industry or healthcare setting, or the equivalent combination of education and experience. Pay Range: $138,100 - $207,100 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Summary The Business Operations Specialist is responsible for enabling clinical trial execution through a combination of supporting implementation and management of clinical trial systems (CTMS, Learning Management System (LMS), TMF, etc.) and clinical records management. This role ensures clinical systems and TMF activities are executed in compliance with Good Clinical Practice (GCP), ICH E6 guidelines, applicable regulatory requirements (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trial Directives), and Arcus SOPs. They work closely with cross-functional teams to support and assist operation of these systems to enhance clinical trial efficiency and utilize effectively as well as ensures TMF remains current, accurate, and inspection ready throughout the trial lifecycle. Responsibilities Clinical Systems Management - Support the support the selection, implementation, configuration, testing, maintenance, training, and closeout of clinical trial systems, including CTMS, eTMF, LMS, and related platforms. - Provide day-to-day system support, troubleshooting, and guidance to study teams to ensure effective and compliant system use. - Assist with user access management, training coordination, system integrations, and vendor/CRO oversight activities. - Perform data entry, reconciliation, and quality checks across clinical systems and tracking tools. - Maintain study, site, and personnel records, including data cleaning, standardization, and error resolution. - Develop and maintain metrics, dashboards, and reports to support operational oversight. - Analyze clinical business processes to identify gaps and opportunities for optimization and process improvement. Provide support to address existing and potential gaps in clinical systems. - Escalate system, data, or process risks and work cross functionally to resolve issues - Participate in and support activities related to audits, inspections, and inspection readiness/ preparedness. Clinical Records (TMF) Management - Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF - Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs - Review and classify documents collected from internal and external sources - Reconcile essential documents to avoid duplication - Support study teams with the TMF quality review process - Perform QC and maintenance of eTMF for assigned studies - Perform data entry and reconciliation in various clinical systems and tracking tools - Provide input on revision of TMF related Work Instructions and SOPs - Support the management and oversight of the CRO study-specific trial master files - Support the coordination of the transfer of study-specific trial master files from the CRO - Follow up on quality findings - Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing. - Participation in audit, inspection readiness preparation and inspection activities as needed - Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF - May provide training and mentoring activities for new and current staff - Develop metrics, reports, and TMF tools/trainings - Act as stand-in leading team meetings, managing team tasks as needed Qualifications - Bachelor’s or Associates degree (preferably in a scientific or related field) and 5+ years of experience in clinical operations, TMF management, clinical systems, or related roles within the pharmaceutical or biotechnology industry. - Demonstrated experience supporting clinical trial systems (e.g., CTMS, eTMF, LMS, EDC, IRT); Veeva Vault experience required. - Strong understanding of clinical trials, clinical trial processes and TMF requirements, including ICHGCP, GDP, and regulatory expectations. - Familiarity with the DIA TMF Reference Model and industry best practices. - Strong organizational, analytical, and problem-solving skills with high attention to detail. - Ability to manage multiple priorities in a fast paced, high-volume environment. - Strong communication and interpersonal skills; ability to collaborate effectively across functions and with external partners. - Proficiency with Microsoft Office and clinical trial management systems. - Team oriented, flexible, and able to work independently while maintaining integrity and high ethical standards. - Position may require occasional travel - Physical Requirements Office Setting - Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. This role can be based at our Hayward, CA or Brisbane, CA location (preferred) or can be remote based. Arcus Biosciences is an equal opportunity employer. #LI-JS1 #LI-Remote

Position Summary Department: Information Technology Status: Full-Time Shift: Monday- Friday, afterhours and weekends as needed Location: Remote, will come on site in Orlando, FL as needed At Orlando Health, we are ordinary people with extraordinary individuality, working together to bring help, healing and hope to those we serve. By daily embodying our over 100-year legacy, we reinforce our reputation as a trusted and respected healthcare organization that delivers professional and compassionate care to our patients, families and communities. Through our award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities, our 27,000+ team members serve communities that span Florida’s east to west coasts and beyond. ORLANDO HEALTH - BENEFITS & PERKS: All Inclusive Benefits (start day one) - Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees. Forbes Recognizes Orlando Health as a Best-In-State Employer - Forbes has named Orlando Health as one of America's Best-In-State Employers for 2024. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, VP (HR). "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued. Employee-centric - Orlando Health has been selected as one of the “Best Places to Work in Healthcare” by Modern Healthcare Position Overview The Senior Clinical Informaticist, partners with clinical, administrative and analytics leadership to lead in the development and implementation of a methodology and strategic plan for clinical informatics in the organization. The partnership will entail collaboration with clinicians, health administrative leaders and IT teams. Following the strategic plan, the Clinical Informaticist leads stakeholders through the process of procurement, implementation, maintenance, and optimization of IT products. In addition, the Clinical Informaticist integrates knowledge of clinical workflows with an understanding of data and analytics to help identify and lead in the development of new solutions to existing healthcare problems. Leading multi-functional teams involving technical and clinical experts to anticipate identify, and help resolve challenges faced by the organization is essential. Responsibilities Essential Functions Building Relationships and supporting current IT products • Strong customer service orientation and ability to follow issues to resolution. • Builds strong relationships with stakeholders and team members across the continuum of care. • Acts as a liaison with the IT teams and the assigned business units requiring IT based solutions. • Communicates initiatives and outcomes and with stakeholder groups. • Coordinates the execution and use of IT products. • Provides in-person support for stakeholders related to the use and adoption of existing and new clinical technologies. • Provides effective level of clinical, business and technical support to assist the IT Operations and the IT Products teams in effectively supporting and maintaining mission critical IT products. New product request process • Effectively participates in Governance processes for new requests. • Collaborates with stakeholders to guide technology choices, • Translates technical concepts into operational and clinical terms to meet the needs of stakeholders. Analysis of current business processes • Leads teams that perform business and process analysis to align the clinical needs with information technology. • Evaluates workflow and makes recommendations for practice change enabled by utilization of IT products • Evaluates current information technologies to determine opportunities for optimization, enhancements and workflow changes to improve user experience and clinical outcomes. • Provides complex analysis and evaluation of systems, processes and workflows to ensure corporate system needs are met in a cost effective and timely manner. • Assists in the development of new business processes and workflow issues to ensure the best possible outcomes for patients and assists in making Orlando Health the best place to work. • Enables and facilitates clinical insights and actions to improve patient outcomes. • Reviews IT usage, services, technology, and department specific projects in order to identify, forecast and develop IT needs. Analytics • Collaborates with clinicians and health administrative leaders to develop meaningful analytics. • Works with the Software and Data Sciences teams to develop workflows that support existing algorithms, rules, and predictive analytics to continually enhance the value of information provided to users. • Provides critical analysis and evaluation of IT tools and recommends revision of clinical systems, process and workflow to ensure achievement of positive patient outcomes and Orlando Health goals. Staff Requirements • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards. • Maintains compliance with all Orlando Health policies and procedures. • Participate in projects as needed and performs other duties as assigned. Other Related Functions • Ability to participate in multiple activities and tasks simultaneously. • Knowledge of current healthcare trends and developments and associated business needs in the clinical information technologies. • Knowledge of the deployment and usage of clinical information technologies and electronic medical record technologies. • Demonstrates knowledge of regulatory and agency requirements. • Maintains current knowledge of HIPAA, privacy and confidentiality standards to ensure both vendor and internally developed software are compliant. Qualifications Education/Training • Bachelor’s degree in Nursing, Healthcare Informatics, Healthcare Administration, or relevant related clinical or IT field, OR Associate’s degree plus four (4) years’ experience in related area of study • Strong verbal and written communication skills. Licensure/Certification Licensed clinician with current license in area of specialty by the Department of Health (i.e. RN, RRT, PT, etc.) required. Experience • Five (5) years of clinical analytics experience in an acute care or ambulatory patient setting, required. • Healthcare IT experience required.