Clinical research coordinator jobs in Carmichael, CA - 21 jobs

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management). **Key Accountabilities** May include but not limited to the following: Clinical Trial Operational Delivery - May support a single study or multiple studies - May lead a study with limited scope (e.g., Survival Follow-up) - Liaises with cross-functional lines as appropriate - May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Demonstrated oral and written communication skills - MS Office Suite Experience Required- including Word, Excel, and Power Point - Proficient in written and spoken English - Proficient in local language (as applicable) - Willingness to travel as required for key company meetings Knowledge and Experience: - Pharmaceutical experience beneficial but not required - Therapeutic Area (TA) specific experience beneficial - 2 years medical monitoring experience preferred Education: - Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience - If no degree in Life Sciences, must have significant experience in clinical development (>5 years) \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

As the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Essential Responsibilities:** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership + Support adoption of new technology or clinical applications through advocacy and evidence + Participate in customer presentations regarding use of Interventional products for institution research purposes + Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns + Grow technology leadership mindshare through joint scientific presentations and publications + Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products + Study new technology concepts and leverage expertise to move initiatives forward **Qualifications/Requirements:** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field + Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research + Experience with imaging modalities and dose analysis + Knowledge of Interventional procedures, anatomies, clinical practice + Knowledge of Interventional products including IGS product line and Advantage Windows applications + Excellent customer relationship management and collaboration skills + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( **Desired Characteristics:** + 5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $100,000.00-$150,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** Yes

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

Primary Purpose Under the guidance of the Associate Director at the Center for Innovation and Translation, the Clinical Research Coordinator ( CIT ) will provide essential operational and administrative support for the PRIMED program, funded by the National Institute of Health ( NIH ), National Institute of Dental and Craniofacial Research ( NIDCR ). The Clinical Research Coordinator will coordinate all phases of clinical research projects, from study documentation creation, regulatory preparation, through participant recruitment, data and sample collections, ongoing documentation and compliance monitoring to study closeout and reporting. The Coordinator will also support the delivery of clinical research education programs and maintain communication with internal and external stakeholders. Key responsibilities include preparing regulatory submissions, managing case report forms and site files facilitating training compliance, maintaining study documentation, supporting financial processing and contributing to NIH reporting requirements. The Coordinator will also assist with broader CIT led innovation, clinical research and translational research projects as needed. The University of the Pacific recognizes that diversity, equity, and inclusion are foundational to the success of our valued students and employees. We prioritize policy and decision-making that demonstrates awareness of and responsiveness to the ways sociocultural forces related to race, gender, ability, sexuality, socioeconomic status, etc., impede or propel students, faculty, and staff. The position is supported until August 2028; It may be extended if sustainable funding sources are identified. Essential Functions The Clinical Research Coordinator will play a pivotal role in executing the multifaceted PRIMED grant awarded by the NIH NIDCR . Collaborating closely with internal and external stakeholders, including collaborators, students, research faculty, clinical faculty, and staff, the incumbent will oversee various aspects of research support to ensure the successful delivery of PRIMED objectives. Program and Study Coordination Support the day-to-day management of the PRIMED program, including study setup, delivery, monitoring, and closeout. Coordinate timelines, track milestones, and ensure program compliance with NIH and institutional guidelines. Organize regular team meetings, take minutes, and track follow-up actions across investigators, staff, and partners. Regulatory and Documentation Oversight Assist in the drafting, formatting, and revision of study protocols and informed consent documents. Coordinate development of regulatory packets for IRB submission, including protocol, consent forms, HIPAA , and recruitment materials. Prepare and maintain essential study documents including the Investigator Site File ( ISF ),regulatory binders and, participant tracking logs. Case Report Forms (CRFs) and Data Management Design and manage electronic and/or paper-based CRFs, ensuring alignment with protocol objectives and data analysis plans. Maintain RED Cap or other research databases, ensuring data integrity, security, and version control. Track data collection and monitor study progress against recruitment and reporting targets. Clinical Study Support Coordinate participant screening, enrollment, consent, and participant scheduling. Support sample collection, processing, and transfer in collaboration with lab and clinical personnel. Conduct or oversee quality checks on study data and sample integrity. Study Monitoring and Auditing Conduct internal audits of study files, CRFs, and regulatory documents to ensure protocol adherence. Training and Education Program Support Coordinate organization and tracking for PRIMED training programs. Track completion and outcomes across student, resident, faculty, and alumni cohorts. Administrative and Financial Management Process program-related expenses and reimbursements grant budgets. Track purchases, manage supply inventory, and coordinate procurement of study materials. Support preparation of budget justifications and documentation. Support for CIT Projects. Contribute to additional innovation, pilot, or commercial research projects led by the Center for Innovation and Translation. Support documentation, meeting coordination, data entry, and stakeholder communication as needed. Community and Research Engagement Assist in developing outreach materials and maintaining contact with alumni and clinical sites for Practice Based Research Network development. Communicate study opportunities and updates through coordinated messaging and event support. Minimum Qualifications Knowledge of: Clinical research protocols and procedures, including protocol development, site file setup, case report form creation, and regulatory documentation. Institutional Review Board ( IRB ) and Good Clinical Practice ( GCP ) compliance requirements. NIH policies and general grant-funded research operations. Data management tools and systems (e.g., RED Cap), including data entry, tracking, and reporting. Intermediate proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook). Ability to: Coordinate complex clinical research studies from start-up through closeout, ensuring accuracy and compliance at each stage. Work independently and collaboratively in a team setting with a proactive, detail-oriented approach. Manage sensitive data, biospecimens, and documentation with high ethical and professional standards. Track and organize multiple workflows, deadlines, and communications across internal and external stakeholders. Learn and implement new digital tools, platforms, and processes for research operations. Experience: Two years' experience in biology, life sciences, or healthcare administration. Education Bachelor's Degree. Working Conditions: Position is full time, eight (8) hours per day, five (5) days per week. Occupational exposure to blood borne pathogens or biohazardous materials may reasonably be anticipated. Personal protective equipment will be provided to reduce or eliminate exposure to routine or limited infectious agents. Occasional travel required. Preferred Qualifications Knowledge of: NIH grant administration procedures and compliance reporting. Clinical study lifecycle management, including protocol development, site activation, participant recruitment, and regulatory documentation. Sample handling and biobank protocol knowledge. Proficiency with RED Cap, IRB submission platforms (e.g., IRIS , i Med RIS ), and data quality control practices. Familiarity with training program delivery in clinical research settings. Ability to: Assist with managing multiple studies, including document control, SOP development, and quality checks. Coordinate logistics for education programs, outreach events, and faculty-student engagement. Communicate clearly and professionally with academic, clinical, and external partners. Maintain discretion, professionalism, and attention to compliance in all aspects of clinical research. Support study audits, documentation review, and data reporting to internal and external funders. Experience: 3+ years of experience in clinical research operations, ideally in an academic or federally funded environment. Experience with IRB processes, informed consent development, CRF creation, and study file documentation. Familiarity with the implementation of training or education programs related to research. Prior use of RED Cap, SharePoint, and project tracking tools preferred. Education: Degree in public health, clinical research, or biomedical sciences. Other: Bilingual skills are helpful. Experience and sensitivity in working with people of diverse backgrounds and cultures. Demonstrated experience in advancing social justice, equity, and inclusion in a university setting. Ability to engage and integrate culturally responsive practices and knowledge in their work.

Collects data for clinical trials research, following general directions. Supports the preparation of study documentation for submission to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports), with limited guidance. Assists with the development and/or implementation of standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance. Learns about providing input on implementing budgeting components for internally funded standard projects. Learns to draft and submit clinical trials applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures. Essential Responsibilities: + Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback. Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work. Assesses and responds to the needs of others to support a business outcome. + Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship. Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports the completion of priorities, deadlines, and expectations. Identifies and speaks up for ways to address improvement opportunities. + Assists in budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard projects. + Conducts clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of clinical trials, studies, and interventions at the site-level; contributing to the development of standard clinical research protocols and other processes of clinical trials with limited guidance; supporting the preparation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens), with guidance. + Supports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines. + Learns to maintain internal and external effective working relationships by: leveraging a working knowledge of how to support important research stakeholders and projects within their unit; communicating, under minimal guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance. + Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) with general directions and limited guidance; assisting with the development of standard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a working knowledge of how to monitor and audit Clinical Trials as well as documenting findings. Minimum Qualifications: + Bachelors degree in Science, Public Health, Health Care Administration, or a directly related field OR Minimum three (3) years of experience in clinical research or a directly related field. Additional Requirements: + Knowledge, Skills, and Abilities (KSAs): Ethical Conduct; Data Quality; Business Relationship Management; Managing Diverse Relationships; Stakeholder Management; Computer Literacy; Accountability; Adaptability; Autonomy; Organizational Skills; Compliance; Laboratory Procedures; Laboratory Equipment; Innovative Mindset Preferred Qualifications: + Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA). + Basic Life Support (BLS) Certification. COMPANY: KAISER TITLE: Clinical Research Coordinator II, Clinical Trials- Sacramento LOCATION: Sacramento, California REQNUMBER: 1396048 External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

The Radiologic Technology Clinical Coordinator is a full-time faculty and administrative position responsible for coordinating, supervising, and evaluating all clinical education components of the Radiologic Technology program. This role oversees RT students assigned to clinical rotations, manages and maintains relationships with clinical sites, ensures student and site onboarding compliance, and provides classroom and/or lab instruction as assigned. The position plays a critical role in maintaining program quality, accreditation compliance, and positive clinical partnerships. Key Responsibilities Clinical Education Oversight Coordinate and oversee all clinical rotations for Radiologic Technology students Assign students to clinical sites and monitor progress throughout the program Conduct regular clinical site visits to evaluate student performance and site quality Serve as the primary point of contact for students during clinical education Address student performance issues, professionalism concerns, and remediation plans Clinical Site Management Recruit, onboard, and maintain relationships with clinical affiliate sites Ensure all clinical affiliation agreements are current and compliant Communicate regularly with clinical instructors and site leadership Resolve clinical site concerns related to student placement, scheduling, or performance Participate in expanding and strengthening the clinical site network Onboarding & Compliance Ensure students complete all clinical onboarding requirements, including but not limited to: Immunizations Background checks Drug screens Orientation documentation Site-specific requirements Track and document compliance using designated clinical tracking systems Ensure clinical documentation meets institutional and accreditation standards Teaching & Instruction Provide didactic and/or laboratory instruction as assigned Participate in curriculum delivery aligned with program outcomes and accreditation requirements Evaluate student academic and clinical performance Maintain accurate grading, attendance, and instructional records Accreditation & Program Support Assist the Program Director with accreditation compliance (e.g., JRCERT, ABHES) Maintain accurate clinical records, evaluations, and outcomes data Participate in programmatic assessment, advisory board meetings, and continuous improvement efforts Support program policies, procedures, and institutional objectives Qualifications Registered Radiologic Technologist (ARRT) in Radiography Minimum of two years of clinical experience in radiography At least one year of teaching or clinical instruction experience Strong organizational, communication, and leadership skills Ability to manage multiple clinical sites and student cohorts Proficiency with clinical tracking systems and basic educational technology Preferred Prior experience as a clinical coordinator or lead clinical instructor Bachelor's degree or higher in Radiologic Sciences or related field Familiarity with JRCERT accreditation standards Work Schedule Full-time position Combination of on-campus instruction, administrative duties, and off-site clinical visits Physical & Professional Expectations Ability to travel to clinical sites as required Professional demeanor when interacting with students, faculty, and clinical partners Commitment to student success, compliance, and program quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we've been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what's possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds. What You'll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include: Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application. Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting. Acting as a clinical interface between the medical community and the business. Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly. Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities. Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems. Supporting EP Sales Representatives in the following areas: Collaborating with sales personnel; Facilitating regional training seminars; Participating in clinical studies/data collection; Troubleshooting; and, Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives. Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management. Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals. Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development. Participating in occasional travel for in-person instruction and live procedure coverage. Required Qualifications Bachelors Degree or equivalent experience. Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews. The base pay for this position is $50,700.00 - $101,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Support ServicesDIVISION:EP ElectrophysiologyLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:YesSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

Posting Date 12/24/2025 9267 Greenback LaneSuite A-2, Orangevale, California, 95662-4863, United States of America DaVita is hiring a Clinical Coordinator to lead outpatient dialysis care for patients with end-stage renal disease. In this role, you'll oversee treatment, guide clinical staff, and ensure the highest standards of care and safety. Key Responsibilities: * Coordinate patient care plans and monitor outcomes * Supervise clinical staff, including PCTs * Ensure safe, compassionate dialysis delivery * Build long-term relationships with patients and families * Work in a fast-paced, team-oriented environment Requirements: * Current RN license and CPR certification * 18+ months RN experience, including 6+ months dialysis * Charge RN readiness approval required * ADN required; BSN preferred * ICU, ER, or Med/Surg experience preferred * CNN/CDN certification a plus * Basic computer skills (MS Word, Outlook) * Flexible schedule, including weekends and holidays What We Offer: * Medical, dental, vision, 401(k) match * PTO and PTO cash-out * Paid training and development * Family and mental health support (Headspace, EAP, child/elder care) Ready to lead and make a difference? Apply now. #LI-CM7 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. The Wage Range for the role is $51.00 - $67.00 per hour. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

The Clinical Coordinator coordinates the clinical and/or community placement activities of the pre-licensure or graduate nursing programs within the School The Clinical Coordinator coordinates the clinical and/or community placement activities of the pre-licensure or graduate nursing programs within the College of Nursing for an assigned campus. Assists the team to develop, coordinate, assigns, and maintain clinical and/or community site relationships. Collects and/or maintains documentation required by the clinical and/or community sites to be compliant with policies and standards. Collaborates with the specific placement director for program-specific needs. Duties and Responsibilities: I. Coordinate Clinical Placements 1. Work with CCT leadership and Clinical Directors of pre-licensure to ensure adequate clinical/community placements (sites, preceptors, and required hours) are available. 2. Communicate effectively with the relevant individuals and groups (internally and externally) reporting any concerns to the Director(s) of Clinical Affairs for follow-up. 3. Provide guidance and support for students to prepare for onboarding and progression through the entire clinical/community placement process. 4. Maintain ongoing communication with the Clinical Coordinators and Placement Directors regarding updates (e.g., new policies, new trainings) from clinical partners that may have an impact on student placement. 5. Participate in meetings with clinical partners locally and/or regionally as requested by CCT leadership. 6. Maintain, or have immediate access to, the documents required by clinical partners to demonstrate student and faculty compliance during audits. 7. Develop and maintain proficiency in multiple applications for all clinical placement activities. II. Procurement and Management of Clinical Sites 1. Maintain relationships with existing sites/preceptors to ensure a positive relationship. 2. Represent the Samuel Merritt University School of Nursing in a positive and professional manner. 3. Prepare, and review for accuracy, the clinical contract request forms and submit to the SMU Contract Specialist for processing. 4. Monitor contract status of all clinical sites (new and existing contracts) and notify Directors when contracts expire or need renewal. 5. Maintains an accurate database to document status of student displacements and the resolution. III. Compliance A. CLINICAL SITES 1. Maintain a current repository of all SMU required preceptor documents and manage the distribution of these documents to clinical sites as necessary. 2. Submit required clinical/community documents to the sites in a timely and complete manner. 3. Submit course syllabi and objectives to clinical/community partners/preceptors prior to the start of the course at their requests. 4. Communicate with the hospital partners regarding Preceptorship and provide necessary paperwork/documentation for the student rotation. 5. Submit to the clinical/community sites student rosters, contact information and other required information prior to clinical rotations. B. STUDENTS 1. Ensure students have submitted all required documents for their specific clinical site assignments in a timely manner. 2. Assist AA to confirm all student compliance requirements are complete and uploaded into the SMU system as required by Samuel Merritt University programs and various clinical sites. 3. Ensure students are aware of required documents and/or logs they need to maintain during their clinical/community rotations. This includes providing students with instructions on how to access, complete and submit. 4. Maintain access to My Clinical Exchange and other similar systems (i.e., accounts) are up to date; monitor for account expirations 5. Confirm access for students to site specific systems, i.e., OAR (Sutter) and UC Davis. Identity; monitor for expiration dates and need for renewal. C. FACULTY 1. Ensure clinical faculty have submitted all required documents for their specific clinical site assignments in a timely manner. 2. Assist AA to ensure all faculty compliance requirements are met and uploaded into the SMU system as required by Samuel Merritt University programs and various clinical sites. 3. Ensure access to My Clinical Exchange and other similar systems (i.e., accounts) are up to date; monitor for account expirations 4. Confirm access for faculty to site specific systems, i.e., OAR (Sutter,) UC Davis and NUIDs Identity; monitor for expiration dates and need for renewal. IV. General Administrative Support 1. Receive and direct inquiries from clinical/community sites, preceptors, and students to appropriate administrators, faculty, and staff, as needed 2. Assist AA with scheduling on campus electronic health record training for faculty (PL) and students prior to start of clinical/community rotation 3. Participate in new student orientation, as appropriate for each program, to provide clinical/community overview and unique requirements 4. Assist AA to schedule/arrange new faculty orientation at the clinical/community site; maintain documentation of completion date. 5. Collaborate with Program Chair/Course Managers to ensure clinical/community faculty are appropriate for each clinical setting. MINIMUM QUALIFICATIONS Self-starter that takes initiative and independently develops solutions. Strong leadership and evaluation skills. Excellent communication, written, oral and negotiation skills. Excellent interpersonal skills that would support optimal public relations for CCT and the SoN. Good judgement and creative critical thinking to solve problems and to develop alternative solutions. Handle privileged information in a confident manner. Ability to organize and prioritize workload. Effective project planning and implementation skills. Excellent organizational and operational skills. Excellent concentration and attention to details required for an extended period of time Extensive computer experience and the ability to use the Microsoft Office Suite (Word, Excel, PowerPoint). Ability to speak effectively with public, co-workers, faculty and student populations. Ability to receive and interpret detailed information through written and verbal communication. Ability to read and write clear documents PHYSICAL REQUIREMENTS Considerable time is spent at a desk using a computer. Physical ability to lift, bend and flex the upper body. Ability to lift up to 20-30 pounds; Ability to push and pull carts. May be required to attend conference and training sessions within Bay Area. May be required to travel occasionally to offsite campuses and agency locations. EDUCATION, QUALIFICATIONS AND/OR EXPERIENCE Bachelor's Degree Required SUPERVISORY RESPONSIBILITIES Assist with supervising/managing student employees and work-study projects Employee Status:RegularExemption Status:United States of America (Non-Exempt) Time Type:Full time Job Shift: Pay Range: $33.37 to $35 - hourly (non exempt) Samuel Merritt University currently provides base salary ranges for all positions-on job advertisements-in the United States based on local requirements. Individual compensation will ultimately be determined based on a variety of relevant factors including but-not limited to qualifications, geographic location, and other relevant skills.

The Assisted Living Clinical Coordinator is responsible for coordinating overall resident care in assisted living at Ponte Palmero. Key tasks of the role include conducting resident assessments for existing residents as well as potential new residents, managing and setting expectations for care with staff, conduct apartment visits to ensure highest level of care is being provided within our stated policies and procedures and Department of Social Services, conducting audits, training and disciplinary actions as needed, and visiting residents who are out of the community. The position serves as a liaison with hospital personnel, physicians, community organizations, in-home care agencies, hospice and other health related service agencies to provide the necessary and appropriate care to the residents. The position reports directly to the Assisted Living Director and will also be responsible for providing direct care to residents on a as needed. The Company is an Equal Opportunity Employer. ESSENTIAL FUNCTIONS, DUTIES AND RESPONSIBILITIES The essential duties and responsibilities described below are representative of those an employee encounters while performing the basic functions of the position. While every effort has been made to identify the essential functions of the position, it in no way states or implies that these are the only duties you will be required to perform. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or is an essential function of the position. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of the position. On-call availability for all shifts, available to coordinate with scheduling and finding coverage as needed for shifts. Support the ALD and Med Room Supervisor with taking call-off notices from direct care staff. Daily walking rounds to observe care with caregiving staff and observations of medication room practices to ensure all staff in AL are trained properly, meeting the care and medication needs of residents and acting within licensing requirements. Report all incidents and deaths to licensing. Review “End of Shift” and “Med Tech to Med Tech” logs each working day. Supervises and acts as a resource and support for care staff. Confirms, without fail, that all medications are passed/reconciled without incident. Process resident returns from the hospital, skilled nursing facility etc. This includes assessing the resident's immediate status, receiving all discharge instructions and requesting of medications from pharmacy and/or doctor's office. Implement and maintain database for resident 602's, list of residents with dementia diagnosis and residents who can leave property unassisted. Obtain updated 602's annually for residents with dementia diagnosis per #6 below. This list should be provided to transportation and maintenance departments on a monthly basis. Oversee the management of resident chart binders, including but not limited to making sure all 602's are up to date (as per state regulations) binders are complete and organized and that all paperwork is in compliance with state law. Review outside agency documentation. Handle emergencies and first aid as needed. Ensure alert charting completed per policy. Conduct and coordinate the completion of resident assessment program in accordance with current rules, regulations, guidelines and company policies that govern resident assessment; administer pre-admission and periodic assessments to all residents and monitor changes in status. Ensure that an initial resident assessment is completed prior to each resident's move-in date and a comprehensive care plan is completed upon move-in. Provide reassessments on a regular basis. Complete reassessment when a resident comes back from an out of community stay. Ensure resident's paperwork, charts and medications are ready for new move-ins. Conduct care conference meetings with residents and responsible parties if any, and obtain signatures as required. Complete billing status changes as needed and submit to BOD. Interview potential residents and families, complete a pre-placement assessment and needs and services plan, and obtain medical records and other requirements as outlined in Title 22 for an admission to the community. Conduct interviews and observations on a continual basis of the residents to alert the Executive Director, family and others of changes in the physical or emotional health of the resident. Conduct weekly service plan meetings. Oversee wound care weekly. Responsible for all information to be contained in AL Advantage. Complete all required data entry into AL Advantage to ensure maintenance of resident care information. Ensure that AL Advantage Resident Care Profile and assignment sheets are completed timely and all required documentation has been completed. This includes but is not limited to adding new residents, filing incident reports, filing death reports. Process resident returns from the hospital, skilled nursing facility etc. This includes assessing the resident's immediate status, receiving all discharge instructions and requesting of medications from pharmacy and/or doctor's office. Ensure all changes to orders are processed timely with any new medications “in house.” Develop methods for coordination of nursing services with other resident services to ensure the continuity of the residents' total regimen of care. Act as care manager and resource person for the residents and their families (especially for those residents determined by ED as “difficult.”) Contact physicians, family and others to obtain specific orders for care and represent the property to professional personnel, residents and the community. Communicate with residents, families, physicians, outside providers etc. as needed. Monitor resident care (showered, appearance, clothing etc.) Supports administration in referral development and maintaining high census. Per state of California regulations, as a “mandated reporter” you must report all known or suspected incidents of resident abuse of dependent adults or elders. MINIMUM QUALIFICATIONS Minimum Age Requirement: Must be at least 18 years of age. Education: High school diploma or equivalent. Certifications as required by the state. Mathematical Skills: Ability to perform calculations in support of personnel actions, budget, and other financial responsibilities. Reasoning Skills: Understand and conceptualize concepts as well as demonstrate ability to make decisions in stressful situations. Oral/Written Communication Skills Be able to explain ideas and to communicate complex ideas to a wide audience (employees, residents, family members, governmental agencies, public, etc.), both in writing and verbally. Equipment Used: Be proficient in basic office equipment (including a personal computer) for the purpose of accomplishing and maintaining a high level of job performance. Physical Effort: Must be mobile and able to perform physical requirements of the job. Good physical health verified by a health screening, including a chest x-ray or an intradermal test result not more than 6 months prior or seven (7) days after employment. Personal Characteristics: Ability to show sincere compassion towards cognitively impaired older adults. Demonstrates genuine concern for the physical and emotional needs of older people and their families. Working Conditions: Well-lighted office with appropriate ventilation and temperature levels. Other: (As required by Title 22) Employee must pass a criminal record clearance prior to beginning work in the community. Employee must possess current first aid training. PHYSICAL AND MENTAL REQUIREMENTS N/A = Not required in this position O = Occasional: Performed or encountered 1% to 33% of work time F = Frequent: Performed or encountered 34% to 66% of work time C = Constant: Performed or encountered 67% to 100% of work time N/A O F C Supervision/ Managing Supervising X Managing X Work Setting Sitting for long periods X Operating standard office machines X Operating computer X Moving freely about property X Answering/using telephones X Stock Handling Examples of Weights Lifted and Frequency A ream of paper or less (5 pounds) X A small record storage box (5-20 pounds) X A case of bottles (20-30 pounds) X Furniture, bales, crates, drums (80 pounds or more) X Resident Care Pushing wheelchair X Turning residents X Helping residents walk X Lifting residents X Helping residents sit up X Mobility Walking X Standing X Bending X Climbing X Crawling X Visual Requirements Overall vision X Color perceptions X Depth perceptions X Reading/close up work X Field of vision/peripheral X Dexterity Handling X Reaching X Grasping X Fingering X Feeling X Hearing/Talking Hearing normal speech X Hearing on the telephone X Hearing faint sounds X Talking in person X Talking on the telephone X Calculating/Interpreting Calculating X Comparing X Editing X Evaluating X Interpreting X Organizing/Planning Organizing X Consulting X Analyzing X Planning X Designing X Documenting/Implementing Documenting X Specifying X Coordinating X Implementing X Presenting X Emotional/Psychological Factors - Exposure to Stressful situations X Trauma, grief, death X Public contact X Decision making X Concentration X Environmental Conditions Noise X Dirt, dust, smoke, fumes X Cold, heat (indoors) X Cold, heat (outdoors) X Blood Borne pathogens X Additional Requirements to the Position (List) Compliance with the Property's Exposure Control Plan. X Compliance with the Property's Blood Borne Pathogens Standard. X Compliance with the Property and Department's safety and emergency procedures. X Responsible for resolving, reporting, and anticipating potentially hazardous conditions. X

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Collects data for clinical trials research, following general directions. Supports the preparation of study documentation for submission to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports), with limited guidance. Assists with the development and/or implementation of standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance. Learns about providing input on implementing budgeting components for internally funded standard projects. Learns to draft and submit clinical trials applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures. Essential Responsibilities: * Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback. Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work. Assesses and responds to the needs of others to support a business outcome. * Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship. Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports the completion of priorities, deadlines, and expectations. Identifies and speaks up for ways to address improvement opportunities. * Assists in budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard projects. * Conducts clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of clinical trials, studies, and interventions at the site-level; contributing to the development of standard clinical research protocols and other processes of clinical trials with limited guidance; supporting the preparation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens), with guidance. * Supports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines. * Learns to maintain internal and external effective working relationships by: leveraging a working knowledge of how to support important research stakeholders and projects within their unit; communicating, under minimal guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance. * Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) with general directions and limited guidance; assisting with the development of standard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a working knowledge of how to monitor and audit Clinical Trials as well as documenting findings.

Minimum Qualifications Must be licensed as a Registered Pharmacist or eligible for licensure in California; if not licensed in California, licensure within one year of hire is required. Pharm.D. with PGY1 residency or fellowship or equivalent experience is required. Preferred Qualifications PGY2 in ambulatory care or acute care Strong background in ambulatory or acute care pharmacy practice. Excellent interpersonal and communication skills (written and verbal). Experience and sensitivity in working with people of diverse backgrounds and cultures. Demonstrated experience in advancing social justice, equity, and inclusion in a university setting. Ability to engage and integrate culturally responsive practices and knowledge in their work

The Assisted Living Clinical Coordinator is responsible for coordinating overall resident care in assisted living at Ponte Palmero. Key tasks of the role include conducting resident assessments for existing residents as well as potential new residents, managing and setting expectations for care with staff, conduct apartment visits to ensure highest level of care is being provided within our stated policies and procedures and Department of Social Services, conducting audits, training and disciplinary actions as needed, and visiting residents who are out of the community. The position serves as a liaison with hospital personnel, physicians, community organizations, in-home care agencies, hospice and other health related service agencies to provide the necessary and appropriate care to the residents. The position reports directly to the Assisted Living Director and will also be responsible for providing direct care to residents on a as needed. The Company is an Equal Opportunity Employer. ESSENTIAL FUNCTIONS, DUTIES AND RESPONSIBILITIES The essential duties and responsibilities described below are representative of those an employee encounters while performing the basic functions of the position. While every effort has been made to identify the essential functions of the position, it in no way states or implies that these are the only duties you will be required to perform. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or is an essential function of the position. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of the position. On-call availability for all shifts, available to coordinate with scheduling and finding coverage as needed for shifts. Support the ALD and Med Room Supervisor with taking call-off notices from direct care staff. Daily walking rounds to observe care with caregiving staff and observations of medication room practices to ensure all staff in AL are trained properly, meeting the care and medication needs of residents and acting within licensing requirements. Report all incidents and deaths to licensing. Review “End of Shift” and “Med Tech to Med Tech” logs each working day. Supervises and acts as a resource and support for care staff. Confirms, without fail, that all medications are passed/reconciled without incident. Process resident returns from the hospital, skilled nursing facility etc. This includes assessing the resident's immediate status, receiving all discharge instructions and requesting of medications from pharmacy and/or doctor's office. Implement and maintain database for resident 602's, list of residents with dementia diagnosis and residents who can leave property unassisted. Obtain updated 602's annually for residents with dementia diagnosis per #6 below. This list should be provided to transportation and maintenance departments on a monthly basis. Oversee the management of resident chart binders, including but not limited to making sure all 602's are up to date (as per state regulations) binders are complete and organized and that all paperwork is in compliance with state law. Review outside agency documentation. Handle emergencies and first aid as needed. Ensure alert charting completed per policy. Conduct and coordinate the completion of resident assessment program in accordance with current rules, regulations, guidelines and company policies that govern resident assessment; administer pre-admission and periodic assessments to all residents and monitor changes in status. Ensure that an initial resident assessment is completed prior to each resident's move-in date and a comprehensive care plan is completed upon move-in. Provide reassessments on a regular basis. Complete reassessment when a resident comes back from an out of community stay. Ensure resident's paperwork, charts and medications are ready for new move-ins. Conduct care conference meetings with residents and responsible parties if any, and obtain signatures as required. Complete billing status changes as needed and submit to BOD. Interview potential residents and families, complete a pre-placement assessment and needs and services plan, and obtain medical records and other requirements as outlined in Title 22 for an admission to the community. Conduct interviews and observations on a continual basis of the residents to alert the Executive Director, family and others of changes in the physical or emotional health of the resident. Conduct weekly service plan meetings. Oversee wound care weekly. Responsible for all information to be contained in AL Advantage. Complete all required data entry into AL Advantage to ensure maintenance of resident care information. Ensure that AL Advantage Resident Care Profile and assignment sheets are completed timely and all required documentation has been completed. This includes but is not limited to adding new residents, filing incident reports, filing death reports. Process resident returns from the hospital, skilled nursing facility etc. This includes assessing the resident's immediate status, receiving all discharge instructions and requesting of medications from pharmacy and/or doctor's office. Ensure all changes to orders are processed timely with any new medications “in house.” Develop methods for coordination of nursing services with other resident services to ensure the continuity of the residents' total regimen of care. Act as care manager and resource person for the residents and their families (especially for those residents determined by ED as “difficult.”) Contact physicians, family and others to obtain specific orders for care and represent the property to professional personnel, residents and the community. Communicate with residents, families, physicians, outside providers etc. as needed. Monitor resident care (showered, appearance, clothing etc.) Supports administration in referral development and maintaining high census. Per state of California regulations, as a “mandated reporter” you must report all known or suspected incidents of resident abuse of dependent adults or elders. MINIMUM QUALIFICATIONS Minimum Age Requirement: Must be at least 18 years of age. Education: High school diploma or equivalent. Certifications as required by the state. Mathematical Skills: Ability to perform calculations in support of personnel actions, budget, and other financial responsibilities. Reasoning Skills: Understand and conceptualize concepts as well as demonstrate ability to make decisions in stressful situations. Oral/Written Communication Skills Be able to explain ideas and to communicate complex ideas to a wide audience (employees, residents, family members, governmental agencies, public, etc.), both in writing and verbally. Equipment Used: Be proficient in basic office equipment (including a personal computer) for the purpose of accomplishing and maintaining a high level of job performance. Physical Effort: Must be mobile and able to perform physical requirements of the job. Good physical health verified by a health screening, including a chest x-ray or an intradermal test result not more than 6 months prior or seven (7) days after employment. Personal Characteristics: Ability to show sincere compassion towards cognitively impaired older adults. Demonstrates genuine concern for the physical and emotional needs of older people and their families. Working Conditions: Well-lighted office with appropriate ventilation and temperature levels. Other: (As required by Title 22) Employee must pass a criminal record clearance prior to beginning work in the community. Employee must possess current first aid training. PHYSICAL AND MENTAL REQUIREMENTS N/A = Not required in this position O = Occasional: Performed or encountered 1% to 33% of work time F = Frequent: Performed or encountered 34% to 66% of work time C = Constant: Performed or encountered 67% to 100% of work time N/A O F C Supervision/ Managing Supervising X Managing X Work Setting Sitting for long periods X Operating standard office machines X Operating computer X Moving freely about property X Answering/using telephones X Stock Handling Examples of Weights Lifted and Frequency A ream of paper or less (5 pounds) X A small record storage box (5-20 pounds) X A case of bottles (20-30 pounds) X Furniture, bales, crates, drums (80 pounds or more) X Resident Care Pushing wheelchair X Turning residents X Helping residents walk X Lifting residents X Helping residents sit up X Mobility Walking X Standing X Bending X Climbing X Crawling X Visual Requirements Overall vision X Color perceptions X Depth perceptions X Reading/close up work X Field of vision/peripheral X Dexterity Handling X Reaching X Grasping X Fingering X Feeling X Hearing/Talking Hearing normal speech X Hearing on the telephone X Hearing faint sounds X Talking in person X Talking on the telephone X Calculating/Interpreting Calculating X Comparing X Editing X Evaluating X Interpreting X Organizing/Planning Organizing X Consulting X Analyzing X Planning X Designing X Documenting/Implementing Documenting X Specifying X Coordinating X Implementing X Presenting X Emotional/Psychological Factors - Exposure to Stressful situations X Trauma, grief, death X Public contact X Decision making X Concentration X Environmental Conditions Noise X Dirt, dust, smoke, fumes X Cold, heat (indoors) X Cold, heat (outdoors) X Blood Borne pathogens X Additional Requirements to the Position (List) Compliance with the Property's Exposure Control Plan. X Compliance with the Property's Blood Borne Pathogens Standard. X Compliance with the Property and Department's safety and emergency procedures. X Responsible for resolving, reporting, and anticipating potentially hazardous conditions. X

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Primary Purpose Under the general supervision of the Department Chairperson, performs various duties related to the endodontic department and patient management for the Advanced Education Program in Endodontology. University of the Pacific recognizes that diversity, equity, and inclusion is foundational to the success of our valued students and employees. We prioritize policy and decision-making that demonstrates awareness of, and responsiveness to, the ways socio-cultural forces related to race, gender, ability, sexuality, socio-economic status, etc. impede or propel students, faculty, and staff. Essential Functions Receive visitors; assist students and schedule appointments for meetings with faculty; receive and screen calls; Answer telephones, greet patients, respond to inquiries, schedule and confirm patient appointments. Perform duties related to patient intake; prepare and input patient information and acquire insurance information; verify patient accountability for completeness and accuracy. Respond to and resolve patient questions or concerns; refer patient to appropriate individual as necessary. Manage scheduling of follow-up and case recalls for endodontic residency patients. Assist in tracking and scheduling patients for any clinical research work. Take minutes at faculty department meetings; support department chairs with roles held within dental organizations and associations. Uploading documents, grades, oversee course curriculum database updates; compile results from surveys; reserve rooms. Process leave and travel request forms; record/track submission of time records online. Coordinate paperwork for current and incoming faculty with appropriate personnel. Maintain confidential documentation to include personal contact information and DEA numbers. Process reimbursements to faculty/students; prepare authorization for payment ( ATP ) forms and salary/debit vouchers; coordinate, maintain, place and track orders for office/clinic supplies; interact with vendors, arrange hotel stay and honorarium for speakers. Provide coordination and support for department special projects and events (i.e., graduation, interview day and AAE receptions etc) to include planning, implementation and follow-up processes; maintain master program calendar. Participate and support long term goals and strategies to meet changing needs of the endodontic department and dental school. Perform all other duties as assigned by the Department Chairperson or the program director. Minimum Qualifications Knowledge of: Office methods and procedures. Principles of business letter and report writing. Intermediate level Microsoft Word, Excel, Access, PowerPoint, Adobe Photoshop, and e-mail systems. Dental terminology and treatments. Dental insurance procedures. Insurance billing procedures. Ability to: Utilize clinic management system to enter and manage patient information. Use educational computer programs/classroom technology utilized student assessments as well as classroom and seminar support Explain financial obligations for dental procedures as necessary. Resolve patient concerns regarding billing and financial obligations. Compose professional correspondence. Maintain high level of confidentiality of information. Experience: Minimum of 3 years increasingly responsible administrative support experience in a dental school or dental clinic. Education: High school diploma or equivalent. Working Conditions: Position is five (5) days per week, seven and one-half (7.5) hours per day. Preferred Qualifications Knowledge of: Learning management systems (Canvas) desirable. Ability to: Manage time, organize duties/assignments, and set priorities to meet multiple deadlines. Take initiative in the organization and maintenance of departmental responsibilities, projects, and procedures. Work productively under pressure with minimal supervision. Demonstrate excellent attention to detail, problem solving, judgment, customer service and follow-through skills. Project a professional image, demonstrate strong interpersonal skills and communicate in a collegial and professional manner with administrators, faculty, staff, residents and students. Communicate effectively and professionally with all constituencies. Work independently or as part of a team. Experience: Previous experience in an academic setting highly desirable. Other: Experience and sensitivity in working with people of diverse backgrounds and cultures. Demonstrated experience in advancing social justice, equity, and inclusion in a university setting. Ability to engage and integrate culturally responsive practices and knowledge in their work.