Clinical research associate jobs in Woodland, CA - 22 jobs

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

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 + 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 $97,600.00-$146,400.00 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

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_

Under general direction of the Associate Director for the Statewide Assessments Office within the Assessment Development & Administration Division the Education Research and Evaluation Administrator I manages the Science Office. Duties include, but are not limited to the following: Provides leadership, managerial direction, and supervision of consultant, analytical, and support staff for responsibilities of the Science Office. Monitor the item development, test administration, scoring, psychometric standards, and reporting of the California Science Test (CAST) and the California Alternate Assessment (CAA) for Science. Direct the formulation of strategies to implement the policies, programs, and priorities of the Superintendent of Public Instruction, the California Department of Education and the State Board of Education. Consult with key internal and external staff; oversee plans for communication and outreach that support the implementation of the CAST, the CAA for Science, and science instructional resources for Tools for Teachers. Oversee the preparation of Science Office work products. Determine tasks, timelines, and due dates; assign tasks to staff and communicate responsibilities and expected work products; provide feedback on and approve deliverables; ensure policy and format consistencies; oversee the preparation of budgetary documents; oversee contracts administered by the office; analyze proposed legislation that impacts on the work of the Office; and ensure that correspondence meets Department standards and policies. Represent the Office to the field. Meet and work collaboratively with representatives of key local, state, and national programs. You will find additional information about the job in the Duty Statement. Working Conditions TELEWORK OPTION HYBRID This position is headquartered in Sacramento and may be eligible for a hybrid telework schedule for eligible applicants residing in California. A hybrid telework schedule includes working remotely and physically reporting to the office. Minimum Requirements You will find the Minimum Requirements in the Class Specification. * EDUCATION RESEARCH AND EVALUATION ADMINISTRATOR I Additional Documents * Job Application Package Checklist * Duty Statement Position Details Job Code #: JC-502425 Position #(s): 174-570-2641-002 Working Title: Education Research and Evaluation Administrator I Classification: EDUCATION RESEARCH AND EVALUATION ADMINISTRATOR I $9,428.00 - $11,808.00 New to State candidates will be hired into the minimum salary of the classification or minimum of alternate range when applicable. # of Positions: 1 Work Location: Sacramento County Telework: Hybrid Job Type: Permanent, Full Time Facility: Assessment Development & Admin. Div. Department Information The California Department of Education (CDE) oversees the state's diverse and dynamic public school system, which is responsible for the education of more than six million children and young adults in more than 10,000 schools with 295,000 teachers. The CDE and the State Superintendent of Public Instruction are responsible for enforcing education law and regulations; and for continuing to reform and improve public elementary school programs, secondary school programs, adult education, some preschool programs, and child care programs. The CDE's mission is to provide a world-class education for all students, from early childhood to adulthood. The CDE serves our state by innovating and collaborating with educators, schools, parents, and community partners, preparing students to live, work, and thrive in a highly connected world. Special Requirements Personal Leave Program 2025 Effective July 1, 2025, the State of California implemented the Personal Leave Program (PLP) 2025. This position is subject to PLP 2025 and will have a monthly base pay reduction of 3% in exchange for 5 hours of leave credits through June 2027. The salary range(s) shown on this job posting does not reflect the salary reduction. Application Instructions Completed applications and all required documents must be received or postmarked by the Final Filing Date in order to be considered. Dates printed on Mobile Bar Codes, such as the Quick Response (QR) Codes available at the USPS, are not considered Postmark dates for the purpose of determining timely filing of an application. Final Filing Date: 12/31/2025 Who May Apply Individuals who are currently in the classification, eligible for lateral transfer, eligible for reinstatement, have list or LEAP eligibility, are in the process of obtaining list eligibility, or have SROA and/or Surplus eligibility (please attach your letter, if available). SROA and Surplus candidates are given priority; therefore, individuals with other eligibility may be considered in the event no SROA or Surplus candidates apply. Applications will be screened and only the most qualified applicants will be selected to move forward in the selection process. Applicants must meet the Minimum Qualifications stated in the Classification Specification(s). How To Apply Complete Application Packages (including your Examination/Employment Application (STD 678) and applicable or required documents) must be submitted to apply for this Job Posting. Application Packages may be submitted electronically through your CalCareer Account at ********************** When submitting your application in hard copy, a completed copy of the Application Package listing must be included. If you choose to not apply electronically, a hard copy application package may be submitted through an alternative method listed below: Address for Mailing Application Packages You may submit your application and any applicable or required documents to: Department of Education Human Resources Division-Mail In Attn: C&P PC 4670 /JC 502425 1430 N Street, Ste. 1802 Sacramento, CA 95814 Address for Drop-Off Application Packages You may drop off your application and any applicable or required documents at: Department of Education Department of Education Drop-Off Attn: C&P PC 4670/JC 502425 1430 N Street (Lobby Drop-Off Box) Sacramento, CA 95814 08:00 AM - 05:00 PM Required Application Package Documents The following items are required to be submitted with your application. Applicants who do not submit the required items timely may not be considered for this job: * Current version of the State Examination/Employment Application STD Form 678 (when not applying electronically), or the Electronic State Employment Application through your Applicant Account at ********************** All Experience and Education relating to the Minimum Qualifications listed on the Classification Specification should be included to demonstrate how you meet the Minimum Qualifications for the position. * Resume is required and must be included. * Degree and/or School Transcripts * Other - Cover Letter * Statement of Qualifications - Interested individuals MUST submit a Statement of Qualifications (SOQ) with their application. Resumes, letters, and other materials do not take the place of the SOQ. The SOQ should have a title of "Statement of Qualifications, Your Name," be no more than 2 pages, no smaller than 12-point font, and address the following: * 1. Experience with the three-dimensional CA NGSS including implementation and assessment. * 2. Experience performing the responsibilities outlined in this job announcement. Provide specific examples in handling various activities. * 3. Experience communicating effectively to a variety of audiences both orally and in writing. Provide specific examples including the communication method. * 4. Experience collaborating with internal and external groups, on high profile or politically sensitive educational issues, particularly in the area of assessments. Applicants requiring reasonable accommodations for the hiring interview process must request the necessary accommodations if scheduled for a hiring interview. The request should be made at the time of contact to schedule the interview. Questions regarding reasonable accommodations may be directed to the EEO contact listed on this job posting. Desirable Qualifications In addition to evaluating each candidate's relative ability, as demonstrated by quality and breadth of experience, the following factors will provide the basis for competitively evaluating each candidate: * Ability to communicate effectively, both orally and in writing * Strong interpersonal skills; ability to work tactfully with diverse stakeholder groups on education issues * Experience managing program staff and providing leadership in the area of assessments or a similar field. * Ability to work independently and collaboratively to ensure quality deliverables and meet project deadlines * Highly productive in a fast-paced work environment with shifting priorities * Experience with large-scale assessments in education * Experience with monitoring contracts * Experience with California Next Generation Science Standards (CA NGSS) Benefits The State of California provides comprehensive benefits packages determined by the employee's bargaining unit. Some of these benefits include: * Medical benefits, including health, dental, and vision insurance * Paid holidays: 11 paid State holidays, 1 personal paid holiday, and 2 professional development days * 401(k) and 457(b) Plans (Savings Plus) * Employee Assistance Program * Commute Program More benefit information can be found on CalHR's website: Benefits Summary Contact Information The Human Resources Contact is available to answer questions regarding the application process. The Hiring Unit Contact is available to answer questions regarding the position. Human Resources Contact: Munita Prasad ************** ****************** Hiring Unit Contact: Lori Hanks ************** ***************** Please direct requests for Reasonable Accommodations to the interview scheduler at the time the interview is being scheduled. You may direct any additional questions regarding Reasonable Accommodations or Equal Employment Opportunity for this position(s) to the Department's EEO Office. EEO Contact: Randi Thompson, EEO Officer ************** ****************** California Relay Service: ************** (TTY), ************** (Voice) TTY is a Telecommunications Device for the Deaf, and is reachable only from phones equipped with a TTY Device. Important Application Instructions * How to Apply for state jobs: ************************************************************* * Electronic applications submitted through your CalCareer account are highly recommended. * DO NOT include any confidential information on any documents you submit for this job vacancy. Confidential information that should be excluded or removed from these documents includes, but is not limited to, your Social Security Number (SSN), birthdate, age, student identification number, driver license (unless required), examination results, LEAP status, and marital status. * Incomplete or late application packages will NOT be considered. * For experience to be considered, your STD 678 (state application) must be complete and include dates, accurate hours per week, total time worked, duties and responsibilities, and contact names and phone numbers of supervisors. Applications that are submitted blank or with "see resume" in place of duties performed will be considered incomplete. * For civil service classifications, do not use working titles. * If you choose not to submit electronically and are mailing or dropping off your hard copy State Application (STD. 678), use the revised 06/2024 version. * If you are using education to meet the minimum qualifications, you must submit a copy of your transcripts or diploma. Foreign transcripts must be accompanied by an academic credential evaluation. List of approved agencies: Foreign Transcript Evaluation (CL-635) * Please note that the CalCareer system will not allow you to make changes to your application once it is submitted. * Candidates who reside outside of the State of California may be admitted to the job interview but must provide proof of residence in California prior to being eligible for appointment. For general information about getting a job with the state, please view the job series videos here: Work4CA:How to Get a State Job Series. Examination Information To be considered for this job opportunity, applicants must be reachable on an employment list, have transfer eligibility, or have reinstatement eligibility. If you are new to California State service and you do not have list eligibility, you must take the exam for this classification. The examination bulletin(s) may be viewed on the California Department of Education Web page at: Open Examinations - Jobs at CDE (CA Dept of Education) or at the link below: Education Research and Evaluation Administrator I: ******************************************************************************** Equal Opportunity Employer The State of California is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation. It is an objective of the State of California to achieve a drug-free work place. Any applicant for state employment will be expected to behave in accordance with this objective because the use of illegal drugs is inconsistent with the law of the State, the rules governing Civil Service, and the special trust placed in public servants.

This role is primarily patient-facing, involving tasks such as screening and recruitment, managing source documentations, and documenting in electronic medical records (EMR). You will be responsible for ordering labs, screening, consenting, and enrolling patients in oncology trials, following them throughout their therapy. Most of the time will be spent in the clinic, working closely with doctors and seeing patients during visits. Your role includes ensuring questionnaires are completed and conducting research procedures that go beyond clinical norms. Responsibilities * Screen, consent, and enroll patients on oncology trials. * Follow patients through the course of therapy. * Manage patient appointments and ensure protocol compliance. * Interact with nursing staff and medical assistants. * Collaborate with clinical staff to obtain insurance authorizations. * Schedule appointments with infusion nurses. * Ensure research procedures are conducted properly and within timeframes. * Assist patients in understanding and dealing with side effects. Essential Skills * Minimum of 2 years of experience as a Clinical Research Coordinator. * 4+ years of oncology clinical research coordinator experience for roles. * Experience in clinical research and patient recruitment. * Ability to pre-screen patients and conduct chart reviews. * Bachelor's degree. Additional Skills & Qualifications * Experience with patient study enrollment. * Excellent organizational skills. * Ability to read and interpret protocols. * Knowledge of side effects management. * Enthusiastic attitude. Work Environment You will be part of a prestigious cancer center, contributing to cutting-edge research in oncology. The role involves working with dedicated investigators on novel treatments. The work schedule is Monday to Friday, 8 AM to 5 PM, with some flexibility based on clinic schedules. You will be required to be on-site for office visits daily. Trials include pharmaceutical-sponsored phases I, II, and occasionally III, investigator-led protocols, and various grant mechanisms through national clinical trial groups. The clinical team is divided into disease teams, with clinical staff working in the cancer center and data management staff working separately. Disease team allocation will be determined by candidate experience and business needs. Job Type & Location This is a Contract to Hire position based out of Sacramento, CA. Pay and Benefits The pay range for this position is $30.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Sacramento,CA. Application Deadline This position is anticipated to close on Dec 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct May serve as Clinical Trial Lead for one or more trials May lead or support trial level activities for one or more trials with the necessary supervision May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members Collaborate and liaise with external partners (e.g., KOLs) Seek out and enact best practices with instruction Provide regular and timely updates to manager/management as requested Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required Conduct literature review Submit clinical documents to TMF Develop site and CRA training materials and present these at SIVs and Investigator meetings Review clinical narratives Monitor clinical data for specific trends Develop Data Review Plan in collaboration with Data Management Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.) Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry) Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations Ability to understand assigned protocol(s) and their requirements Basic knowledge skills to support program-specific data review and trend identification Intermediate medical writing skills and medical terminology Basic planning/project management skills (develop short range plans that are realistic and effective) Detail-oriented with commitment to quality Basic knowledge of disease area, compound, current clinical landscape Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees Intermediate critical thinking and problem-solving skills Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools) Domestic and International travel may be required. Compensation: Brisbane, CA and Cambridge, MA $173,390-$210,110 New Jersey $150,770 - $182,701 San Diego, CA and Seattle, WA $165,850-$200,974 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1598007 : Clinical Scientist, Early Development

Clinical Research Coordinator II, Clinical Trials- Sacramento(Job Number: 1396048) Description Job Summary: 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.Qualifications 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

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.

1150 E Leland Rd, Pittsburg, California, 94565, United States of America DaVita is Hiring! We are looking for a Clinical Coordinator to join our amazing team! If you are looking to give life in an outpatient dialysis center considering DaVita. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way, consider DaVita and apply today! Some details about this position: * At least 6 months dialysis experience is required. * Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. * Training may take place in a facility or a training clinic other than your assigned home clinic * Potential to float to various clinics during and after your training * You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can Expect: * Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. * Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. * Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. * Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. * You will work with your head, heart and hands each day in a fast paced environment. What We'll Provide: We offer competitive compensation plus an amazing benefit packages: * Medical, Dental & Vision * 401K (matching) * Retirement Plans * Hospital Care Plan * Paid Training * PTO and Paid Holidays * PTO cash out * Health Saving Account * Flexible Spending Account * Professional Growth Opportunities * Tuition Reimbursement * Employee Stock Purchase Options * Critical Care Insurance * Life & Disability Insurance Requirements: * Current Registered Nurse (RN) license in the state of practice * Current CPR certification required * At least 18 months of registered nursing experience * Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required * Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred * Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred * Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree * Current CPR certification required * Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system * Supervisory experience preferred; willingness, desire, and ability to supervise required * Basic computer skills and proficiency in MS Word and Outlook required 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 Diversity & 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 an affirmative action employer. As such, 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. Applications are accepted on an ongoing basis. #LI-NL1 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 Diversity & 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 an affirmative action employer. As such, 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. Applications are accepted on an ongoing basis. Salary/ Wage Range $52.00 - $68.00 / hour Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************

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

The Clinical Coordinator is responsible for supporting students in the Cardiac Sonography program during their clinical rotations in the Sacramento area. The role ensures that students are progressing through their clinical requirements, meeting competencies, and maintaining accurate records, while also providing support to clinical site staff and addressing issues that may arise with students. Key Responsibilities: Visit each assigned student in the Sacramento area at least once per month. Spend 1-2 hours per visit reviewing competencies, time records, logs, and clinical progress. Monitor Trajecsys regularly to ensure students are meeting required competencies. Provide guidance and support to students regarding clinical expectations and documentation. Serve as a liaison between the school and clinical site staff, offering support as needed. Address and help resolve issues involving students at clinical sites. Communicate concerns or issues with program leadership as appropriate. Time Commitment & Compensation: Estimated 6-10 hours per week. Travel costs reimbursed at the IRS standard mileage rate. Qualifications: Credentialed cardiac sonographer (RDCS or CCI equivalent preferred). Prior clinical or teaching experience strongly preferred. Strong organizational and communication skills. Ability to travel within the Sacramento area.

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.

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-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_

1150 E Leland Rd, Pittsburg, California, 94565, United States of AmericaDaVita is Hiring!We are looking for a Clinical Coordinator to join our amazing team! If you are looking to give life in an outpatient dialysis center considering DaVita. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way, consider DaVita and apply today!Some details about this position: At least 6 months dialysis experience is required. Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. Training may take place in a facility or a training clinic other than your assigned home clinic Potential to float to various clinics during and after your training You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can Expect: Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. You will work with your head, heart and hands each day in a fast paced environment. What We'll Provide: We offer competitive compensation plus an amazing benefit packages: • Medical, Dental & Vision• 401K (matching) • Retirement Plans • Hospital Care Plan • Paid Training • PTO and Paid Holidays • PTO cash out • Health Saving Account• Flexible Spending Account • Professional Growth Opportunities • Tuition Reimbursement• Employee Stock Purchase Options• Critical Care Insurance• Life & Disability InsuranceRequirements: Current Registered Nurse (RN) license in the state of practice Current CPR certification required At least 18 months of registered nursing experience Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree Current CPR certification required Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system Supervisory experience preferred; willingness, desire, and ability to supervise required Basic computer skills and proficiency in MS Word and Outlook required 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 Diversity & 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 an affirmative action employer. As such, 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. Applications are accepted on an ongoing basis. #LI-NL1 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 Diversity & 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 an affirmative action employer. As such, 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. Applications are accepted on an ongoing basis. Salary/ Wage Range $52.00 - $68.00 / hour Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************

**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.

Posting Date 06/02/2025 4040 Lone Tree Way, Antioch, California, 94531-6209, United States of America DaVita is Hiring! We are looking for a Clinical Coordinator (CC) to join our amazing team! If you are looking to give life in an outpatient dialysis center, and leading a team, apply here. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. If you have a desire to deliver care in an empathetic, compassionate way, DaVita is the place or you. Nursing Experience is Required! Some details about this position: * At least 6 months dialysis experience is required. * Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. * Training may take place in a facility or a training clinic other than your assigned home clinic * Potential to float to various clinics during and after your training * You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can Expect: * Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. * Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. * Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. * Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. * You will work with your head, heart and hands each day in a fast paced environment. Requirements: * Current Registered Nurse (RN) license in the state of practice * Current CPR certification required * At least 18 months of registered nursing experience * Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required * Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred * Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred * Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree * Current CPR certification required * Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system * Supervisory experience preferred; willingness, desire, and ability to supervise required * Basic computer skills and proficiency in MS Word and Outlook required What We'll Provide More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings. * Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out * Support for you and your family: Family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave and more * Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform Star Learning. We offer competitive compensation plus an amazing benefit packages: * Medical, Dental & Vision * 401K (matching) * Retirement Plans * Hospital Care Plans * Paid Training * PTO and Paid Holidays * PTO cash out * Health Saving Account * Flexible Spending Account * Professional Growth Opportunities * Tuition Reimbursement * Employee Stock Purchase Options * Critical Care Insurance * Life & Disability Insurance #LI-NL1 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. Salary/ Wage Range $52.00 - $68.00 / hour For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

The 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.