Clinical research associate jobs in Roseville, CA - 892 jobs

Clinical Research Associate - Oncology - Los Angeles, CA ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced monitoring oncology trials required. Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Los Angeles, CA near major HUB airports to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

We are looking for a FREELANCE, PART-TIME CRA to strengthen our clinical operations team in Ventura, Illinois & Ohio! Job Requirements: Bachelor's degree required - preferred qualification in life sciences or medical sciences Minimum 2 years of experience of onsite monitoring activities Profound knowledge of clinical research processes and medical terminology Expert knowledge of ICH GCP, and international and local regulatory requirements Passion for clinical research English language proficiency of minimum level C1 (ref. CEFR) - fluent in written and spoken English Driving license B and ability to travel Job Responsibilities: You would be primarily responsible for monitoring clinical trials and Ensuring that clinical trial is conducted, recorded, and reported in accordance with all applicable international and local regulations and guidelines, good practices, SOPs and Clinical Trial Protocol Ensuring data quality and integrity meet acceptable clinical standards Guaranteeing the rights and safety of patients involved in a study are protected Performing and coordinating all aspects of the clinical monitoring and site management process Conducting remote and on-site visits to assess protocol and regulatory compliance and managing required documentation Developing collaborative relationships with investigational sites, act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability; and you would ensure audit readiness. Serving as facilitator of Clinical Trial conduct in respective area in terms of identifying qualified sites and investigators, facilitating communication between sponsor and regulatory authorities and trial sites. What We Offer: Competitive salary Great work-life balance (You will not be overwhelmed with projects as we believe in quality over quantity) Career growth and development opportunities in a continuous learning culture Friendly environment in a privately owned international company Additional benefits will be discussed during the interview You can apply via the link or send a CV directly to: ******************** * SanaClis is an equal employment opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.

Point person for the facilitation of Clinical Trial Testing; bridges the sponsor and trial execution by managing client relationships and overseeing trial progress. • Manage all aspects of assigned trials under your purview with direction from the lead Project Manager. • Communicate with clinical and regulatory affairs and translate information effectively. This includes all matters; technical, facilitation of workflow, testing sites and customer relations. • Maintain up to date and accurate logs reflecting testing status. • Provide metrics to the site, customer or sponsor as requested. • Resolve issues as they arise. Report critical issues to site leadership. • Provide updates as requested. • Develop SOPs supporting clinical trial testing as required. • Maintain Study Binders/Trial Master File (TMF) as required per GCP. • Perform Quality checks on all deliverables to customers. Partner with other employees to ensure second QC checks when required. • Training other personnel as required. Qualifications and Experiences: • Associate or bachelor's degree (AA or BS). • Two years' experience and/or training in related field such as in a Contract Research Organization, University or Medical setting, or other equivalent experience. • Experience working in regulated environments and familiarity with CAP/CLIA/CDx regulatory compliance and quality assurance standards. • Minimum of 2 years Study Coordinator or Clinical Research or Trial experience required. Compensation $25.00/hr - $27.00/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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

**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.

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!_

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. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. 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_

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.

Great companies need great teams to propel their operations. Join the group that solves business challenges and enhances the way we work and grow. Working at Gainwell carries its rewards. You'll have an incredible opportunity to grow your career in a company that values your contributions and puts a premium on work flexibility, learning, and career development. Summary As a Clinical Screening Coordinator at Gainwell, contribute your skills as we harness the power of technology to help our clients improve the health and well-being of the members they serve - a community's most vulnerable. Connect your passion with purpose, teaming with people who thrive on finding innovative solutions to some of healthcare's biggest challenges. Gainwell empowers you to help clients deliver better health and human services outcomes using innovative technology and solutions, enabling you to design your career for growth, new possibilities, and refinement of your valuable skills. Here are the details on this position. Your role in our mission * Track and manage requests for clinical screening services for Medi-Cal members * Schedule, reschedule and communicate clinical screening appointments for Medi-Cal members * Liaison between Medi-Cal member or member's proxy and the screening provider. Identify and remove barriers to screening appointments such as language assistance and transportation * Maintain and update a list of clinical screening dentists. Be able to match Medi-Cal members to a clinical screening dentist within their region. * Monitor that all scheduled clinical screening appointments are attended and reschedule as needed * Provide administrative support, including but not limited to facilitating appropriate sending, return, evaluation of completeness, entry, and maintenance of clinical screening documents What we're looking for * A minimum of two (2) years of experience in a position in the healthcare/insurance industry, Medicaid and/or Medicare knowledge and experience strongly desired * Knowledge of dental treatment documentation, record keeping, and chart narratives is required. Graduate from an accredited dental assistant program or dental office experience preferred. * Proficiency in software applications used to track service requests * Organizational skills to balance and prioritize work and ability to multi-task * Excellent communication skills, both verbal and written * Exceptional Customer Service What you should expect in this role * Must be a resident of the Greater Sacramento area of California * This posting is intended for pipelining. We will accept applications on an ongoing basis. #LI-ONSITE #LI-CM1 The pay range for this position is $30,500.00 - $43,500.00 per year, however, the base pay offered may vary depending on geographic region, internal equity, job-related knowledge, skills, and experience among other factors. Put your passion to work at Gainwell. You'll have the opportunity to grow your career in a company that values work flexibility, learning, and career development. All salaried, full-time candidates are eligible for our generous, flexible vacation policy, a 401(k) employer match, comprehensive health benefits, and educational assistance. We also have a variety of leadership and technical development academies to help build your skills and capabilities. We believe nothing is impossible when you bring together people who care deeply about making healthcare work better for everyone. Build your career with Gainwell, an industry leader. You'll be joining a company where collaboration, innovation, and inclusion fuel our growth. Learn more about Gainwell at our company website and visit our Careers site for all available job role openings. Gainwell Technologies is an Equal Opportunity Employer, where all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical condition), age, sexual orientation, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Job Description Apply Here: ******************************************************************************* Come and join our team! We are a local growing private medical practice specializing in the diagnosis and treatment of patients with diseases of the retina and vitreous. We are looking for individuals who would like to establish a career in healthcare working with nationally recognized physicians. We provide on the job training giving you the ability to grow and advance your skills along with gaining innovative knowledge. Established in 1977, we have locations all over Northern California including Sacramento, Grass Valley, Roseville, Stockton, Modesto, Merced, Fairfield, Elk Grove, Folsom, Yuba City and Chico. Our physicians are nationally known, and we continue to be on the leading edge of retina care by utilizing the latest equipment and both participating in and designing new clinical trials to advance the state of care for retinal diseases. Join 250+ other team members working for our nationally recognized retina specialty practice in a fast paced, high volume medical office. We are currently participating in several trials at two of our office locations and have a growing clinical research department. The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. We seek a full-time clinical research assistant to support our clinical research department. Although you must be able to work independently, you will be working directly with physicians, patients, research coordinators, clinical and business office staff and with pharmaceutical sponsor representatives to correctly and efficiently execute clinical research protocols. Collaboration and being a team player are essential to the success of this role. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Observe Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Observe, assist, collect and record all necessary data for follow up Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Process and ship laboratory biological samples for analysis Perform intraocular pressure checks after injections Perform trial frame refraction and visual acuity testing Perform other duties as assigned

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

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.

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.

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

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 the Sponsor's 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. **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 the Sponsor's 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 Site Care Partner 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 Site Care Partner 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 the Sponsor's credibility, scientific leadership and in order to facilitate their 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 **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#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.

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_

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.