Clinical Trials Associate jobs at Eikon Therapeutics - 345 jobs

This is a hybrid per diem position offering flexibility to work between 0 and 40 hours per week, depending on departmental needs. Scheduling will be determined by the hiring manager in alignment with operational priorities. At this time, we can only consider applicants who are able to commute to our Los Angeles work location several times per week and who reside within a reasonable commuting distance. The hybrid schedule typically consists of two remote workdays and three days spent either onsite or in the field, based on project and program requirements. Preferred Qualification: Proficiency in the Thai language is strongly preferred. Please note that per diem team members are not eligible for health benefits, but this role provides an excellent opportunity to gain valuable experience, contribute to meaningful work, and enjoy a flexible schedule. Cedars-Sinai's Cancer Research Center for Health Equity (CRCHE) and Community Outreach & Engagement team are seeking a passionate and community-oriented Clinical Research Coordinator (CRC I) - Per Diem to support the implementation of the ASPIRE (Asian American Prospective Research) study. This important initiative focuses on advancing community-based research within the Thai community, helping to improve cancer prevention, screening, and health outcomes. In this role, you will play a key part in developing community partnerships, engaging participants, and ensuring the successful implementation of ASPIRE's goals through culturally responsive outreach and collaboration. The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Duties and Responsibilities Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Assists with patient research billing. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Department Specific Duties & Responsibilities 5% - Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of non-complex research studies. 5% - Collects, evaluates, and abstracts clinical research data; may assist in designing data collection/abstraction tools. Enters and processes clinical research data into sponsor-provided Electronic Data Capture (EDC) systems. 5% - Completes Case Report Forms (CRFs) in accordance with study protocols and sponsor requirements. 5% - Assists with prescreening potential research participants for various clinical trials. Schedules participants for research visits and procedures. Provides supervised patient contact or independent contact for long-term follow-up participants. 5% - Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB), including the submission of Adverse Events, Serious Adverse Events, and Safety Letters per federal and local guidelines. 5% - Assists with clinical trial budgets, study-related billing, and patient research billing activities. 5% - Prepares and ships biological samples; maintains study supplies, kits, and inventory. 5% - Ensures compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, IRB requirements, HIPAA standards, and all institutional and federal guidelines. Maintains strict patient confidentiality. 5% - Serves as a point of contact for external sponsors for select trials; responds to sponsor inquiries and may attend meetings regarding study activity under supervision. Additional Study-Specific Duties Pulmonary Function Lab Assists with prescreening of potential study participants. Maintains organized paper and electronic research files. Assists with preparing manuscripts, correspondence, and other research documents. Conducts literature reviews to support study activities. Neuroscience Transports research medications according to protocol requirements. Performs study-related assessments and participant questionnaires. Maintains organized paper and electronic research files. Assists with manuscript preparation and other research documentation needs. Conducts literature reviews for ongoing and upcoming studies. QualificationsRequirements: High School Diploma/GED required. Preferred: Bachelor's Degree preferred. Proficiency in the Thai language is strongly preferred. 1 year Clinical research related experience preferred. Req ID : 13883 Working Title : Clinical Research Associate I (Hybrid, Per Diem) - Thai & Asian Community Health Initiatives Department : Cancer - Research Center Health Equity Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

Responsible for the daily planning, organizing, directing and controlling of the operations of assigned area, in order to meet the needs of all customers, Faculty and support of Medical Center goals and philosophies. The Manager, Research Operations assumes fiscal responsibility through preparation of unit budgets, serves as liaison with Faculty and other personnel, promotes the maximum growth and development of each employee, supports research, participates in both strategic and tactical planning. The Manager, Research Operations is accountable to the Department Chair and/or Institute Executive Director and serves as the primary source of information for the department. She/he maintains competency skills including the ability to interact with Faculty and staff within their assigned area, the Medical Center and throughout the Health System. The Manager, Research Operations plans, organizes, manages and controls the daily operations of their area and works closely with departmental leadership, Faculty, Principal Investigators (PIs), staff and students to provide analytical support and project management in fulfilling the established goals and objectives for the department and organization. Strategizes and collaborates with the Director and senior leadership, along with Academic Affairs regarding development and implementation of policies and procedures. Manages and supervises administrative staff; provides leadership coaching, and opportunities for professional development. The Manager, Research Operations facilitates Human Resource (HR) functions for their area by collaborating with the appropriate HR partners for Faculty and department staff recruitment, visa and immigration assistance, employee relations, compensation, and benefits. Primary Duties and Responsibilities Ensures compliance with state and federal laws, accreditation, professional and regulatory agency standards and licensure requirements. Maintain staff compliance with medical center policies, procedures and protocols. Assumes fiscal responsibility for the department including unit budget preparation, labor and supply cost management, and revenue enhancement. Responsible for tracking and reporting all high-level Capital/Operations projects. Prepares complex or highlevel regular and ad-hoc financial reports for the Department Chair and/or Institute Executive Director. Works closely with leadership to develop processes and tools to monitor research funding and activities for the area. In collaboration with the Department Chair, Institute Executive Director and/or Division Director develops business operations plans for department and for specific programs and services within it. Supervises the research protocols as mandated for research and ensures optimal levels and continuous improvement of quality within their work area. Maintains appropriate quality management and oversight programs. Supervises department employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, coaching, training (e.g. orientation, in-service and continuing education), evaluating performance, compensation, discipline and terminating employment. Interact regularly with PIs and staff to assess team needs, provide information and resolve issues. Promote a team atmosphere and manage staff regarding but not limited to the following: Manage the onboarding of new lab staff, Develop job descriptions, Conduct employee annual appraisals, Identify staffing needs, Conduct probationary period meetings with new staff, and Counsel, coach and terminate staff as appropriate. In collaboration with the Institute Executive Director and/or Division Director, develops business and operations plans for department and for specific programs and services within it. Manages the effective utilization of human resources and supplies within the department, including the development of appropriate staffing and management of productivity. Develop staffing plans in response to research and department activity. Recommend space and other resources for needed services. Participate in the selection of outside sources for needed services. Collaborates with other research, department and clinical/support service managers in other areas to help foster cross-functional process improvement, collaborative teamwork, open communication and problem solving to ensure the effective coordination and integration of services within and between units. Works closely with the Office of Research Administration and designated Research Grant Specialist to ensure all grant awards are appropriately managed and maintained for Faculty holding a primary appointment in the area. Responsible for facilitating the Faculty contracting process in coordination with Academic Human Resources. Performs all other duties as assigned. Department-Specific Responsibilities The successful candidate will provide strategic leadership and operational oversight for the Cancer Clinical Trials Office (CCTO), ensuring the highest standards of regulatory compliance, operational excellence, and program growth across Cedars-Sinai and the Samuel Oschin Cancer Center. Clinical Operations & Regulatory Oversight Provide leadership to ensure all clinical research activities comply with institutional, local, state, and federal regulations, including GCP, ICH, IRB, and NCI/CCSG requirements. Oversee the structure, governance, and operational alignment of the CCTO with Cedars-Sinai Medical Center and the Samuel Oschin Cancer Center. Ensure accuracy, quality, and timely reporting of clinical trial data across all CTMS, databases, and tracking systems, including adverse events, serious adverse events, and protocol deviations. Perform routine quality checks and audits in collaboration with Quality Management to maintain robust QA/QC programs and support internal and external monitoring visits. Program Leadership & Strategic Planning Partner with Principal Investigators, disease teams, and CCTO leadership to advance clinical research initiatives, improve trial activation timelines, and increase patient accrual. Generate and oversee protocol status reports and performance metrics for key stakeholders, including leadership, IRB, and clinical teams. Lead initiatives to improve efficiency, streamline workflows, enhance communication, and support continuous process improvement across clinical research operations. Support expansion of Cedars-Sinai's cancer clinical research programs across the broader cancer network in collaboration with institutional leadership. People Management & Team Development Lead, mentor, and evaluate clinical research staff, including hiring, onboarding, workload management, performance evaluations, and professional development. Standardize training, tools, and processes across the Clinical Operations Unit to ensure consistency and operational excellence. Foster an inclusive, collaborative, and high-performing team culture that supports professional growth and accountability. Financial & Resource Management Oversee clinical trials financial resources, including budget development, monitoring, and forecasting in collaboration with CCTO and SOCCI finance leadership. Prepare and distribute operational and financial reports, including accrual metrics, audit activity, activation timelines, and budget performance. Support enterprise-wide research administration initiatives and serve as a pilot for scalable clinical research support services as appropriate. Stakeholder Engagement & Communication Serve as a liaison between sponsors, CROs, disease teams, and institutional partners to ensure timely communication and resolution of protocol-related issues. Build and maintain strong relationships with internal and external stakeholders, representing Cedars-Sinai with professionalism and integrity. Teamwork, Leadership & Customer Relations Collaborates effectively across multidisciplinary teams to solve problems and achieve shared goals Establishes strong, trust-based relationships with stakeholders and customers Demonstrates responsiveness, accountability, and inclusive practices Shares expertise and supports team success across functions Supervisory & Management Responsibilities Directly supervises staff, including hiring, scheduling, performance management, and corrective action as needed Plans and assigns work to ensure objectives are met within budget and timelines Provides day-to-day leadership, guidance, and oversight to ensure high-quality outcomes Qualifications REQUIREMENTS Bachelor's Degree in Business, Administration, Nursing, or equivalent work experience required 5 years of related supervisory or management experience, with increasing responsibility Preferred Qualifications: Master's Degree (MBA or MPH) strongly preferred 2 years of experience in finance or budget oversight. Knowledge of general accounting and financial analysis. Knowledge of GAAP rules helpful Req ID : 12570 Working Title : Clinical Research Manager, Research Operations Department : Cancer - SOCCI Clinical Research Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Academic/Research Services Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $55.31 - $96.79

Responsible for directing and managing a specified program within the clinical research operations unit, department, or division. Provides leadership, guidance and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance. Ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio. Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s). Primary Duties and Responsibilities Oversees and/or manages the assigned recognized organizational clinical research program and has authority for day-to-day program operations and administration. May be responsible for program development or expansion. Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives. May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials declined by program or department leadership. Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program. Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement potential solutions. May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program. Interfaces with internal and external key stakeholders including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions. Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives. Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program. Interfaces with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance. Researches and analyzes data for evaluating performance of program or program operations, including quality assurance and trends. Makes recommendations to leadership and/or implements program changes based on findings. Provides data and/or summary findings to program participants, stakeholders, leadership, and/or cross-functional teams. Performs quality oversight of clinical trials to include monitoring progress of screening, enrollment, and data submission. Responsible for ensuring protocol compliance and training of staff supporting the program. Plans and supports the department/program leaders during an audit, to include direction for audit prep and any required follow up post audit. Evaluates requests for program exceptions or changes, and determines response, escalating as necessary. Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and/or mentorship pertaining to the program. Provides regular Primary Duties and Responsibilities communication to departments and leaders across the organization. Notifies stakeholders of any changes to the program. May work with cross-functional teams across multiple departments to develop communication and training materials. In conjunction with leadership, responsible for planning, monitoring, and managing program fiscal budgets and financials, and resolves or escalates issues. Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures. May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and enhancements. Monitors program to ensure appropriate governance and program compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program compliance with organizational policies and procedures. Monitors compliance reporting tools and provides summary status reports to the Research Manager, and other stakeholders. May manage staff and/or lead the work of others, including some or all of the following: recruitment, onboarding/off-boarding, training, performance management and professional development of staff. Department-Specific Responsibilities Manage Disease Research Group (DRG) Meetings: Lead and coordinate DRG meetings, ensuring that all necessary information is addressed to support DRG functions. Maintain regular communication with DRG faculty to ensure alignment with DRG needs and future planning. Clinical Issue Resolution: Engage with providers (physicians, advanced practice providers, clinic nurses, and staff) to ensure that clinical issues are identified and addressed promptly and in compliance with policies. Promote Research Excellence: Advance clinical research activities in a safe, compliant, effective, efficient, and collegial manner. Training and Development: Oversee the training and education of clinical research staff within the DRG/team. Conduct baseline competency assessments for new hires, identify areas of opportunity, and develop individualized training plans. Provide ongoing management of staff development, including competency assessments and continued education opportunities. Contribute to the development and delivery of educational in-services to ensure high-quality clinical research performance. Compliance and Quality Oversight: Contribute to the development and monitoring of corrective action plans. Ensure compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures. Strategic Leadership: Actively participate in the strategic planning process of SOCCI's Cancer Clinical Trials Office (CCTO). Represent the CCTO on university and hospital committees and task forces as assigned. Clinical Study Coordination: Independently coordinate studies, including patient screening, informed consent (when IRB- and Nursing Institute-approved), and oversight of study assignments within the group. Supervise research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements. Develop and implement strategies to increase patient enrollment, improve efficiency, train personnel, and identify new research opportunities. Specimen and Clinical Services: Coordinate study participant tests and procedures as required, and handle research specimens (processing, shipping, tracking). Perform phlebotomy services in accordance with CSMC policies and procedures, ensuring accurate specimen labeling and reporting of results. Other Duties: Perform additional responsibilities as assigned to support departmental goals. Qualifications Required Qualifications High School Diploma or GED. Minimum 5 years of experience in management, program/project management, or a related field. Minimum 3 years of experience in a clinical research or related industry setting. Demonstrated experience managing a team, including direct supervision of staff, in a clinical research setting. Familiarity with clinical research operations, including regulatory compliance, study coordination, and staff development. Preferred Qualifications Bachelor's degree in healthcare, management, or a related field. At least 1 year of experience managing clinical trial operations. Req ID : 11205 Working Title : Clinical Research Program Manager (Operations) Department : Cancer - SOCCI Clinical Research Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $45.56 - $77.45

Come join our team! The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. May serve independently as study coordinator for minimal number of noncomplex research studies or projects. What are the Primary Duties & Responsibilities? Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies. Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Completes Case Report Forms (CRFs). Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently. Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines. Assists with clinical trial budgets and patient billing. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities. Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives. Participates in centralized activities such as auditing, Standard Operating Procedure development, etc. May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives. Qualifications Education, Experience & License/Certification Requirements: High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred. One (1) year of clinical research related experience required Certification in Clinical Research (SOCRA or ACRP) preferred About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 13839 Working Title : Clinical Research Associate II - Women's Research Program - Full-Time, On-Site Department : Womens Cancer Program - WCP Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $36.14

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. The Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities Provides research writing activities such as developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols. Serves as an internal advisor for specific departmental activities. Provides guidance regarding project planning, project logistics, and project implementation. Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution. Responsible for specific and assigned aspects of research infrastructure development and/or maintenance. Coordinates research projects at an institutional or departmental level. Communicates project status and improvement areas with leadership in a timely manner. Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Required: Bachelor's Degree required 5 years of experience in area of research specialty required Req ID : 13854 Working Title : Clinical Research Specialist II Department : Cancer - Shared Services Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $37.66 - $64.02

The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance. Primary Duties & Responsibilities: Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Assists with patient research billing. Assists with prescreening of potential research participants for various clinical trials. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred. Experience and Skills: No experience required. One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats. Req ID : 13060 Working Title : Clinical Research Associate I - Heart Institute - Makkar Lab Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered. Cedars-Sinai has an outstanding opportunity for an independent and well-organized contributor to serve as a CLINICAL RESEARCH ASSOCIATE to Dr. Judy Tan to support community-engaged research that develops behavioral and community-based health interventions for LGBTQ+ communities of color. Dr. Tan, Associate Professor, Cancer Research Center for Health Equity, Division of Population Sciences, Department of Biomedical Sciences, is a social psychologist and applies her training in behavioral and prevention sciences to develop innovative interventions for improving health outcomes among marginalized populations in the U.S. This position provides contributions to behavioral and implementation science for the Cancer Research Center for Health Equity. The scope of the work includes research involving participants recruited from the surrounding LA communities and interactions with community-based researchers, academic researchers, and local community organizations and health systems. As Clinical Research Associate, you will be a vital member of an interdisciplinary team led by Dr. Tan, which includes a biostatistician, qualitative data researchers, as well as grant administrative and project management support staff members. Your role will be assisting with both quantitative and qualitative research projects, patient research engagement, and community liaison support. You will take lead roles on project activities, as identified by the team. Data management, coordination, and analysis: (30%) Assist with leading the creation and management of organized research project portfolio with project dashboard for data tracking. Work independently to produce tables, charts, graphs for manuscript and grant preparation from sources including analyst reports, publicly available data, and literature searches. Organize data storage and management for qualitative study (including interviews with cancer patients, caregivers, and affected community members). Organize data storage and management for quantitative projects. Execute basic data analysis (demographic tables, bivariate calculations, evaluation of missing data) of existing data sets to generate research approach and analytic plans. Support process evaluation of a pilot smoking cessation program, including developing evaluation framework, creating and implementing a data collection plan. Human subject research support: (20%) Assist with leading the creation and management of study questionnaires in REDCap. Identify and resolve quality issues with survey administration. Manage revisions of REDCap instrument and protocol. Triage data collection questions for immediate resolution or consultation with team, PI. Assist with leading the development and submissions of IRB study applications, modifications, and renewals. Assist with leading the compliance efforts for sponsoring entities. Patient and stakeholder engagement: (20%) Support the relationship (act as primary liaison) with community partners, through meeting scheduling, regular and proactive email communication, phone calls, and in-person meetings. Support collaboration with community partners to develop and assess project implementation strategies, including outreach strategies, project materials, and workshop content. Manage collaborative curriculum adaptation with multiple community partners. Interact with patients via assisting with qualitative interviews and focus groups. Writing & Grant Development (10%) Assist with leading the development of project narrative/research plans for new grants, including timelines and schedules of deliverables. Write portions of manuscripts in collaboration with the research team and community partners. Provide copy-editing assistance with manuscripts. Conduct independent literature searches and produce summaries to guide project development based on ongoing research findings and future steps. Budget Management (5%) Act as PI proxy in grant expense approvals and FTE certification. Collaborate with department payroll and grant management staff to identify and address any expense errors. Reconcile budgets monthly. Create budget projections; identify budget surplus and deficits. Ensure timely payment of community partner and other service provider invoices. Assess appropriate budgets to charge for new research activities. Website development & management (5%) Develop content for website. Edit content according to stakeholder (community partners') feedback) Edit personal testimonial videos. Respond to and track website inquiries. Act as the primary liaison with graphic designer and web developers. Other administrative duties as needed (5%) Support Dr. Tan and project team with scheduling meetings Plan and co-manage event logistics; act as primary liaison with on-site service providers. Qualifications This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Please note that a cover letter is required as part of the application. The cover letter should explain your interest in this opportunity and how it aligns with your career goals. Applications missing this document will not be considered. Requirements: High School Diploma or GED required A cover letter explaining your interest in this opportunity and how it aligns with your career goals Resume or CV Preferred: Bachelor's degree or equivalent experience in public health or related area. At least 2 years of related experience post-undergraduate degree. Excellent verbal and written communication skills. Working knowledge of community-based research and organizing theories, frameworks, principles, and practices. Experience with program evaluation, specifically process evaluation. Experience managing complex, multi-stakeholder projects. Experience working with marginalized populations related to health issues. Strong interest in minority health & healthcare, racial disparities, social determinants of health with self- motivation for independent learning Commitment to racial and LGBTQ+ justice. Bachelor's level or equivalent analytic skills and understanding (SAS, Stata, R or equivalent). Intermediate or higher level skills of MS Office suite. Interview Process: If selected for an interview, candidates may be asked to complete a brief writing sample and/or a short example exercise or task relevant to the position. Req ID : 10622 Working Title : Clinical Research Associate I - Community & Behavioral Health, Tan Lab (Onsite) Department : Cancer - Research Center Health Equity Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. We invite you to consider this phenomenal opportunity! Dr. Ju Dong Yang, in Department of Medicine, Karsh Division of Gastroenterology and Hepatology is looking for a new Clinical Research Associate I to join the team! The research program of Dr. Ju Dong Yang has been focused on clinical and translational research of liver cancer. Dr. Yang conducted several population-based cohort studies to describe recent trends in liver cancer epidemiology in the United States. As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. This position will be responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I member may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Primary Job Duties and Responsibilities: Ensures compliance with protocol and overall clinical research objectives. Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets and patient research billing. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Department-Specific Responsibilities: May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Qualifications Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or related degree is preferred. Licenses/Certifications: ACRP/SoCRA certification is preferred. Experience: Clinical research experience is highly preferred. Understanding of general research objectives. About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 13803 Working Title : Clinical Research Associate I - Yang Lab - Karsh Division of Gastroenterology and Hepatology Department : Research - General Medicine Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. We invite you to consider this phenomenal opportunity! As a Clinical Research Associate I, you will work under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of non-complex research studies. The incumbent will support objectives of research studies through non-complex tasks such as data collection, pre-screening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Primary Job Duties and Responsibilities: Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Completes Case Report Forms (CRFs). Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets and patient research billing. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Department-Specific Duties: Maintains CITI certification. Compiles, analyzes, and presents work at internal meetings and conferences. Performs data searches and other related administrative tasks. Assists with research protocol writing and development. Assists with prescreening of research participants for various clinical trials. Attends research meetings and monthly conference calls with sponsors. Maintains organized paper and electronic research files. Performs all data collection and data entry tasks for departmental clinical studies. Assists with preparing manuscripts, letters, and other research documents as needed. Coordinates study related activities and subject recruitment with Laboratory Staff. Qualifications Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or related degree is preferred. Experience: One year of clinical research related experience is preferred. About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 13223 Working Title : Clinical Research Associate I - Medically Associated Science & Technology (MAST) Program Department : Associated Sci and Tech Program Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

Join us as we translate today's discoveries, into tomorrow's medicine! Regenerative medicine is a new and developing field that strives to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases, and we're extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai Are you ready to be a part of breakthrough research? The Clinical Research Associate I will work directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care. Additionally, this position will include animal work (injections, dissections, and surgery), sample processing, and cell culture. Primary Job Duties and Responsibilities: Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Assists with patient research billing. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Department-Specific Duties and Responsibilities: Performs data searches and other related administrative tasks. Assists with research protocol writing and development. Transportation of research medications. Performs study related assessments and questionnaires. Assists with prescreening of potential research participants for various clinical trials. Maintains organized paper and electronic research files. Performs all data collection and data entry tasks for department clinical trials. Assists with preparing manuscripts, letters, and other research documents as needed. Responds to sponsor' inquiries regarding protocol start-up activities and recruitment. Performs literature reviews. Attends research meetings and monthly conference calls with sponsors for study updates. Performs cell culture, immunohistochemistry including processing of samples. Performs animal injections, dissections and surgery. Assists with scheduling of visits and assessments. Qualifications Education: High School Diploma or GED is required. Experience and Skills: Clinical Research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to follow regulations. Must possess digital literacy, including Word and Excel, and the ability to use standard office equipment is required. About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 12957 Working Title : Clinical Research Associate I - Regenerative Medicine Institute Department : Research - RMI Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

Grow your career at Cedars-Sinai! The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography. In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance. Primary Duties & Responsibilities: Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Ensures compliance with protocol and overall clinical research objectives. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide. Provides supervised patient contact or patient contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets. Assists with patient research billing. Assists with prescreening of potential research participants for various clinical trials. Schedules patients for research visits and research procedures. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications Education: High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred. Experience and Skills: No experience required. One (1) year of clinical research related experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats. Req ID : 13782 Working Title : Clinical Research Associate I - CA Heart Foundation Department : CA Heart Foundation Business Entity : Cedars-Sinai Medical Care Foundation Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $33

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital in Southern California for Orthopaedics by U.S. News & World Report. Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements! The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only. Primary Duties & Responsibilities: • Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study. • Evaluates and abstracts clinical research data from source documents. • Ensures compliance with protocol and overall clinical research objectives. • Completes Case Report Forms (CRFs). • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. • Provides supervised patient contact or patient contact for long term follow-up patients only. • Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. • Assists with clinical trial budgets. • Assists with patient research billing. • Schedules patients for research visits and research procedures. • Responsible for sample preparation and shipping and maintenance of study supplies and kits. • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. • Maintains research practices using Good Clinical Practice (GCP) guidelines. • Maintains strict patient confidentiality according to HIPAA regulations and applicable law. • Participates in required training and education programs Qualifications Educational Requirements: High School Diploma/GED Bachelors degree in science or related degree preferred Experience: 1-year clinical research related experience preferred Physical Demands: Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. Understanding of general clinical research objectives. Clinical research experience, preferred Req ID : 13483 Working Title : Clinical Research Associate I - Urology Department : Urology Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $32.86

The Clinical Research Data Specialist I manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: Manages data for research studies. Designs forms for data collection. Performs clinical data collection/abstraction. Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data. Produces project reports. Maintains the accuracy, integrity and security of complex, large computerized records systems. Understands regulations, policies, protocols and procedures to control and maintain accurate records . Performs data searches and other related administrative tasks. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Qualifications Educational Requirements: Requires a bachelor's degree or equivalent in education, training and experience. Masters in Public Health preferred Experience: • Analyst experience preferred - Able to multitask in a diverse and demanding environment with frequently shifting priorities. • Proactive, extremely organized and detail oriented. • Strong record of interpersonal engagement. • Able to demonstrate the ability to balance both working independently and collaboratively. Physical Demands: • Able to perform moderate lifting. • Able to sit, stand and walk for prolonged periods of time. • Able to read papers and online documents. • Able to operate standard office equipment. • Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. Req ID : 5528 Working Title : Clinical Research Data Specialist I - Heart Institute Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $39.76

Grow your career at Cedars-Sinai! The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all our patients with cancer. Why work here? Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for. Join our team and contribute to groundbreaking research. The Research Associate II works at a high level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents. The Research Associate II is responsible for ensuring timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations, where applicable. Primary Duties and Responsibilities: Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval. Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process. Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent. Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial. Ensures timely filing of annual renewals and amendment submissions to IRB. Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines. Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB. May help coordinate and prepare for institutional, pharmaceutical and internal audits. Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires. Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities. Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals. Participates in weekly research staff meetings. Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process. Performs administrative duties in a timely manner as assigned. Qualifications Requirements: High School Diploma/GED required. Bachelor's degree preferred. 1 year Clinical research related experience required. #Jobs-Indeed #LI Req ID : 13668 Working Title : Research Associate II - The Angeles Clinic & Research Institute Department : Angeles Research Inst Business Entity : Cedars-Sinai Medical Care Foundation Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $24 - $34.64

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Working closely with the Sr. Clinical Trial Manager and Clinical Operations Team, the Clinical Trial Associate (CTA) contract position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs). The CTA will support the Sr. Director of Clinical Operations and Clinical Trial Managers (CTM) in day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment. This incredible opportunity will put the right candidate at the forefront of medicine, working on ground breaking trials with tremendous potential to impact patient's lives. You will join a team of incredibly dedicated professionals whose talent is matched by their commitment and passion for the work we are doing. A team that remains focused on what's important for the patient and also has an incredible track record of growth and development among them. If you are looking to learn, work hard, and make a difference, we would like to speak with you. Responsibilities Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out Coordinate study documents and training tools for coordination with clinical sites Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders Coordinate study meetings, materials and agendas; record and disseminate decisions and actions Responsible for internal meeting agendas/minutes as applicable Responsible for updating, maintaining and quality control of the eTMF and other document repositories Responsible for study laboratory sample tracking and vendor management support Track new vendors and purchase orders in financial system Coordinate version control of clinical documents, prioritize multiple tasks and/or projects Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages Support Clinical Operations team with specific projects Effectively communicate with study team members and work closely to address challenges Minimum Qualifications BS/BA degree or equivalent and at least 1-3 years experience in clinical operations in Sponsor company Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations Experience with eTMF; ability to directly apply essential document knowledge to file documents Effective communication, organizational and interpersonal/team skills Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred. Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines Participate in inter-departmental workgroups to create or enhance processes Strong attention to quality/detail Good organizational and time management skills Willingness to work in a flexible environment Preferred Qualifications Additional Years of clinical operations experience inside a Sponsor company Experience with global studies, using an outsourced CRO model Experience in clinical drug development with knowledge of First in Human trials Experience with regulatory affairs, including IND/CTA submissions Knowledge of transplant, oncology or cellular therapies Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $40.00 - $50.00 per hour. The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position As a Clinical Trial Management Associate (CTMA), you will serve as a critical inhouse clinical operations partner in the execution, and oversight of Phase I-III global oncology clinical trials. Positioned between the Clinical Trial Associate (CTA) and Clinical Trial Manager (CTM), the CTMA brings increased ownership, autonomy, and judgment to the execution of clinical studies. You will independently manage assigned study responsibilities and help ensure the delivery of high-quality, compliant, and timely trial data in support of our mission to bring transformative therapies to patients. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, CA offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You bring a strong operational mindset, an ability to work independently, and a flexible and collaborative spirit. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence. What You'll Do Proactively support Clinical Study Management team members in the day-to-day execution of global clinical trials, with increasing independence and accountability for specific study components. Collaborate closely with assigned global (gCSM)/regional Clinical Study Management (rCSM) teams, ensuring operational excellence throughout study execution. Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers. Lead the coordination and execution of site start-up assigned activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring excellence inhouse teams. Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times. Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM. Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues. Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance. Coordinate and contribute to key study meetings (e.g., team meetings, vendor meetings, investigator meetings), including agenda development, meeting facilitation, and action item follow-up. Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence. Partner with data manager lead to ensure timely site follow up (assigned sites) for query reconciliation to meet the study milestones (e.g., interim analyses goals, etc.). Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities. Qualifications Bachelor's degree with 5+ years of relevant clinical trial experience (e.g., CTA, study coordinator, or CRA) or a Master's degree with 3+ years of experience. Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight. Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA). Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus. Excellent organizational and time management skills with high attention to detail. Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project). Previous oncology trial experience preferred but not required. Multilingual skills are a plus. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively · Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL · Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. · Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues · Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) · Review compound-specific ICF and develop study-specific ICF templates · Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection · Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents · Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites · May coordinate the preparation, conduct, and presentations at Investigator Meetings · Review monitoring visit reports for completeness, accuracy, and adherence to the protocol · Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation · May conduct UAT for EDC / IRT and data listing review of EDC data for analysis · Compile and review appendices for preparation of clinical study reports · Review and/or create study documents (e.g. newsletters, and various study / site trackers) · Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion · Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately · May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: · None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: · BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, · MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, · Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: · Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: · Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation · Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures · Experience with development of prospective site-selection criteria · Familiar with medical terminology, and basic concepts of clinical research · Ability to deal with time demands, incomplete information or unexpected events · Experience in interactions with outside vendors, e.g., CROs and contract labs · Demonstrated ability to write and present clearly using on scientific and clinical issues terminology · Applies technical standards, principles, theories, concepts and techniques · Advanced computer skills · Good organizational and planning skills · Strong interpersonal skills and communication skills (both written and oral) · Ability to work effectively in a team/matrix environment · Ability to understand technical, scientific and medical information · Demonstrated success in problem-solving · Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: · Works on assigned problems of moderate scope with analysis of situation or data required. · Exercises judgment within defined procedures and practices to determine appropriate action. · Builds productive internal and external working relationships. · Uses professional concepts and company policies and procedures to solve a variety of routine problems. · Demonstrated professional collaboration skills · Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: · Resilient in the context of a rapidly changing environment · Organized with a systematic approach to prioritization · Works independently to meet objectives and completes tasks within established timelines. · Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: · We drive for results, so patients can survive and thrive. · We are resilient in the face of adversity, and tireless in advancing our science. · We celebrate our long history of prolific drug discovery and rigorous drug development. · We unite to launch innovative medicines for difficult-to-treat cancers. · We exist to give people hope - one drug, one patient at a time. · We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: · Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), · Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) · Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: · Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively * Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL * Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues * Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Review compound-specific ICF and develop study-specific ICF templates * Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents * Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites * May coordinate the preparation, conduct, and presentations at Investigator Meetings * Review monitoring visit reports for completeness, accuracy, and adherence to the protocol * Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation * May conduct UAT for EDC / IRT and data listing review of EDC data for analysis * Compile and review appendices for preparation of clinical study reports * Review and/or create study documents (e.g. newsletters, and various study / site trackers) * Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion * Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately * May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: * Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Experience with development of prospective site-selection criteria * Familiar with medical terminology, and basic concepts of clinical research * Ability to deal with time demands, incomplete information or unexpected events * Experience in interactions with outside vendors, e.g., CROs and contract labs * Demonstrated ability to write and present clearly using on scientific and clinical issues terminology * Applies technical standards, principles, theories, concepts and techniques * Advanced computer skills * Good organizational and planning skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to work effectively in a team/matrix environment * Ability to understand technical, scientific and medical information * Demonstrated success in problem-solving * Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: * Works on assigned problems of moderate scope with analysis of situation or data required. * Exercises judgment within defined procedures and practices to determine appropriate action. * Builds productive internal and external working relationships. * Uses professional concepts and company policies and procedures to solve a variety of routine problems. * Demonstrated professional collaboration skills * Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: * Resilient in the context of a rapidly changing environment * Organized with a systematic approach to prioritization * Works independently to meet objectives and completes tasks within established timelines. * Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: * We drive for results, so patients can survive and thrive. * We are resilient in the face of adversity, and tireless in advancing our science. * We celebrate our long history of prolific drug discovery and rigorous drug development. * We unite to launch innovative medicines for difficult-to-treat cancers. * We exist to give people hope - one drug, one patient at a time. * We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: * Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), * Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) * Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: * Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.