Clinical research associate jobs in Folsom, CA - 877 jobs

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

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties and tasks may be assigned. GROWTH * Assist with clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments. * Assist with planning/coordinating patient scheduling to assure timely acceptance of patients and effective staffing levels. * Demonstrate effective use of supplies and staff labor hours. * Responsible for updating all logs and ensuring that dialysis run sheets and logs are sent to billing. * Perform duties as assigned to meet the patient care or operational needs of the clinic. OUTCOMES * Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare. * Work with Administrator to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician, and other healthcare professionals. * Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality. * Assist with program's target goals for patient outcomes in accordance with quality patient care and Company goals. * Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting as delegated by Administrator or Management. OPERATIONAL READINESS * Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements. * Work with Administrator to assure clinic is in compliance with all applicable federal, state, and local laws and regulations. * Assist Administrator with development, implementation and follow up of Corrective Action Plans required for internal and external surveys. * May assume Charge Nurse's responsibilities as needed. * May fulfill responsibility of facility Alternate CEO as delegated by Governing Body. * Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director, and the staff as delegated. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held as delegated. Assure that Quality Assessment & Performance Improvement Program is current at all times as delegated. * Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center if delegated by Administrator. * Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. * Oversee the maintenance of equipment and supplies to meet current laws and regulations. * Responds to all emergencies in clinic. Familiar with emergency equipment and all emergency operational procedures. * Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center. * Know and understand the water treatment and mechanisms of the equipment of the facility. * Assist, when necessary, with disinfection of equipment and supplies including bicarbonate delivery systems and dialysis machines. PARTNERSHIPS * Maintain collaborative working relationship with Medical Director and physicians. * Establish and maintain a positive relationship with all Administrators, area hospitals, agencies, vendors and the community. * Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization. * Respond effectively to inquiries or complaints. STAFF DEVELOPMENT/ RETENTION * Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations. * Serves as a resource/subject matter expert for patient needs and concerns, staff education and in-service sessions as necessary. * Assists with recruitment, training, development, and supervision of all personnel. * Assists with maintaining effective personnel management and employee relations, including evaluating the performance of all personnel and counseling employees. * Uphold management goals of corporation by leading staff in team concepts and promoting a team effort. * Effectively communicate expectations; accept accountability and hold others accountable for performance.

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

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

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.

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_

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

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. 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 Jan 12, 2026. 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.

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.

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

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.

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

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

The 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.

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

WHAT YOU WILL DO As a Clinical Coordinator (RN) you will be responsible for the delivery of safe, quality care of dialysis treatments by assisting the Center Manager (CM) with oversight of the center's operations and by providing direct patient care. The Clinical Coordinator (RN) acts as a team leader who educates and mentors center staff as appropriate. In the absence of the CM, this position is also responsible for the daily management of the center. WHAT WE EXPECT OF YOU You will play a vital role to ensure that we deliver on our Mission to make life better for those with kidney disease and our Vision to be unsurpassed in our individualized experience, our quality, and our compassion. You approach your work with an indisputable sense of greater purpose. Lastly, you are high energy, seek out opportunities to improve the environment for patients and staff, are goal-oriented, and gain deep satisfaction from building relationships. WHAT YOU WILL GAIN Relationships: You will work directly with a multi-disciplinary team that is as passionate as you in making a difference in others' lives. You will become a servant leader, bringing up your team to provide care that is unsurpassed by others in our industry. Impact: You will set the tone that enables our patients to live a better life and address their needs holistically. You will make a difference for our patients so that they do dialysis to live instead of living for dialysis. Growth: You will have formal and informal opportunities for professional growth in a supportive environment. You will become a subject-matter expert and have a wide range of opportunities for career advancement. MINIMUM QUALIFICATIONS Experience One (1) year of nursing experience required; 1 year of hemodialysis nursing required. Supervisor/Charge Nurse experience preferred Education Graduation from an accredited school of nursing or equivalent; BSN preferred License/Certification Current State license as a Registered Nurse Current CPR/BLS for Healthcare certification (or within 3 months of hire) CNN or CDN certification preferred

**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.

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