Clinical research associate jobs in Fremont, CA

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting . Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $113,500 to $133,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit s Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

PRIMARY ROLE Alto Neuroscience is seeking a Clinical Research Associate (CRA) to support the execution of clinical studies across our precision psychiatry portfolio. This role oversees assigned investigative sites, ensuring studies are conducted efficiently, compliantly, and with scientific rigor. The CRA serves as the key liaison between clinical sites and Alto's clinical operations team-driving recruitment, monitoring data quality, and maintaining high standards of Good Clinical Practice (GCP). DUTIES & RESPONSIBILITIES * Manage site activities from initiation through closeout, ensuring compliance with GCP and study protocols. * Monitor study progress, data accuracy, and regulatory documentation. * Train and support site staff on study procedures and investigational product handling. * Identify and resolve site issues promptly to maintain timelines and data quality. * Collaborate cross-functionally to achieve clinical and operational goals. LOCATION Remote with approximately 60% travel SALARY RANGE $75,000- $120,000 depending on qualifications and experience level QUALIFICATIONS * BS in a scientific field or pharmacy, RN, or BSN degree (or equivalent). * 1-3 years of clinical monitoring experience (CRO, biotech, or pharma), , including on-site or remote monitoring experience * Strong understanding of GCP/ICH-E6 and clinical research operations. * Excellent communication, organization, and problem-solving skills. * CCRA certification and experience with rater-administered measures required. Why Alto At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements. #LI - Remote

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, PTO and 401K

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary Job Description ROLE The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIES * Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits. * Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. * Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. * Ensures integrity of CRF data through meticulous and thorough source document review and verification. * Conducts investigational product accountability. * Reviews regulatory binder for required documents. * Works closely with in-house CRAs and data management to resolve queries on discrepant data. * Proactively identifies site issues and develops problem-solving strategies for sites. * Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. * Conducts audit preparation at study sites as needed. * Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. * Manages and resolves conflicting priorities to deliver on commitments. * Complies with ICH GCP guidelines, FDA regulations, and company SOPs. * Participates in industry and client meetings. * Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE * BS/BA from an undergraduate program or equivalent experience * 2 years of clinical research experience TECHNICAL COMPETENCES & SOFT SKILLS * Ability to travel. * Proven ability to be careful, thorough, and detail-oriented. * Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. * Self-starter who thrives in a collaborative, yet less structured team environment * Ability to problem-solve unstructured or ambiguous challenges. * Strong command of English, both written and verbal. * Excellent communication and interpersonal skills with customer service orientation. * Proficient with MS Office Suite, particularly Word and Excel. * Permanent authorization to work in the country where you are applying. Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Clinical Research Associate (CRA) The Clinical Research Associate (CRA) will be responsible for managing multiple aspects of clinical trials. This includes assisting with study start-up, ongoing monitoring, data management, and analysis, as well as ensuring compliance with study protocols and ethical standards. This role reports to the Senior Clinical Research Leader. Key Responsibilities: Prepare essential clinical study documents, including informed consent forms and source documents. Assist with the initiation and set-up of clinical trial sites. Develop and maintain comprehensive documentation required throughout the clinical study lifecycle. Conduct regular site monitoring visits to oversee data collection and ensure strict adherence to study protocols. Review and validate collected data for accuracy, completeness, and alignment with source documentation. Maintain up-to-date study files, including all regulatory and study-specific documentation. Ensure compliance with regulatory standards, including GCP, ICH guidelines, and IRB requirements. Qualifications: Bachelor's degree in a relevant clinical research or life sciences field. Minimum 3-5 years' experience in clinical research, with a strong background in site monitoring. Demonstrated experience in clinical trial design and data analysis. Skills & Competencies: Proven ability to work independently with a high level of initiative. Collaborative team player with flexibility to adapt in dynamic or uncertain environments; willingness to travel as needed. Excellent written and verbal communication skills. Strong ability to critically review scientific literature and interpret clinical evidence. Advanced analytical and problem-solving abilities. Compensation and Benefits The salary range for this position is $80-$100k. In addition to a competitive market-based salary, Sciton provides an opportunity to participate in equity/stock incentive programs, a profit-sharing bonus, and a comprehensive benefits package, including 401(K) with matching. FULL-TIME/PART-TIME Full-Time POSITION Clinical Research Associate LOCATION Palo Alto, CA (HQ) ABOUT THE ORGANIZATION SCITON is an industry leader and manufacturer of medical aesthetic lasers and light source technologies. With a vision to improve people's lives, our top-tier devices are built to order with integrity by pioneering, customer-focused, and results-driven individuals. At the heart of it, innovation is a fundamental cornerstone of our culture. We strongly believe that new ideas can come from anyone, anywhere, at any time and embrace an open-door culture that welcomes and fosters individuals who are creative, driven, passionate, and willing to take the lead with us. Join us for an opportunity to grow and make an impact. Life at Sciton: At Sciton, people matter. We are more than a company; we are a family, which is why we give all our employees: The support, recognition, and room to grow their careers within Sciton. Empowerment to develop their creative genius and encouragement to be lifelong learners. Incentives for creativity and innovation across the organization.

Role OverviewThe Clinical Trial Research Scientist evaluates clinical study protocols, trial designs, endpoints, statistical plans, and study results. This role emphasizes methodological rigor, documentation clarity, and accurate interpretation of safety and efficacy outcomes. What You'll Do- Review clinical trial protocols and identify methodological strengths or gaps - Analyze endpoints, inclusion/exclusion criteria, and study controls - Interpret trial results and summarize safety and efficacy findings - Validate statistical analysis plans for completeness and accuracy - Identify operational or scientific risks in trial execution - Support recurring evaluations of clinical documentation and study outputs What You BringMust-Have:- Experience in clinical research, biostatistics, or pharmaceutical science - Strong understanding of trial methodology and regulatory standards - Ability to interpret trial data and communicate findings clearly Nice-to-Have:- Experience with Phase I-IV trials or specific therapeutic areas

Description and Requirements JOB STATUS: Full-time WORK SCHEDULE: Mon-Sun 8-9 hours per day (5 days per week) flexibility requested COMPENSATION: $33.00 rate per hour Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support. Main Responsibilities * Receive participants at work and guide them through the data collection in a controlled environment. * Follow COVID-19 sanitization procedures after each session. * Represent and promote the TELUS AI brand * The moderator will report to the Site Manager. * Have all participants complete a survey at the end of each session. * Ensure all data collection is done per project guidelines and upload the data. * Assist the Anthropometric moderators in performing body measurements that require close proximity with participants in minimal clothing, including marking the participants with a pen and collecting measurements of different body parts using high-precision technology. * Any additional task needed. Minimum Requirements * Technical/troubleshooting skills; address fundamental problems with launching apps and uploading data * Familiarity with iOS and Mac OS * Experience with data collection and data management * Experience with video recording * Able to commit to a weekly schedule for the duration of the project * Ability to interact professionally with project participants * Experience with progress tracking and reporting, comfortable with Excel or Sheets TELUS International Values: TELUS International recognizes and embraces the importance of values in our ever-changing workplace. To be successful, all applicants must demonstrate behaviors that are reflective of our values: * We embrace change and initiate opportunity * We have a passion for growth * We believe in spirited teamwork * We have the courage to innovate At TELUS International, we are committed to diversity and equitable access to employment opportunities based on ability. TELUS Digital will never ask for any monetary deposit, credit card information, or bank account information to complete a job application. When emailing candidates, our recruitment and sourcing teams only use email addresses that end with telusdigital.com or telusdigital.ai. If you are unsure whether a job offer is legitimate or suspect that TELUS Digital's business name is being used for recruitment fraud, please report this immediately to our Talent Acquisition Team at TINA_**********************************. Additional Job Description Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support. EEO Statement At TELUS Digital, we enable customer experience innovation through spirited teamwork, agile thinking, and a caring culture that puts customers first. TELUS Digital is the global arm of TELUS Corporation, one of the largest telecommunications service providers in Canada. We deliver contact center and business process outsourcing (BPO) solutions to some of the world's largest corporations in the consumer electronics, finance, telecommunications and utilities sectors. With global call center delivery capabilities, our multi-shore, multi-language programs offer safe, secure infrastructure, value-based pricing, skills-based resources and exceptional customer service - all backed by TELUS, our multi-billion dollar telecommunications parent. Equal Opportunity Employer At TELUS Digital, we are proud to be an equal opportunity employer and are committed to creating a diverse and inclusive workplace. All aspects of employment, including the decision to hire and promote, are based on applicants' qualifications, merits, competence and performance without regard to any characteristic related to diversity.

Company DescriptionJobs for Humanity is partnering with Stanford University to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located. Company Name: Stanford University Job Description At the Sean N. Parker Center for Allergy and Asthma Research, the world's leading scientists, physician-scientists, and research teams come together to study and understand the molecular underpinnings of allergies and asthma. We are committed to finding causes, treatments, and cures for allergies and asthma, and bringing these to children, adults, and their families at local and global levels. Transforming lives with innovative science and compassionate care. Duties include: Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS: Prior experience in a clinical research setting Bachelors degree in a related field EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong interpersonal skills. Proficiency in Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License. PHYSICAL REQUIREMENTS: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORKING STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************** The expected pay range for this position is $72,000 to $92,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with: Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. A caring culture. We provide superb retirement plans, generous time-off, and family care resources. A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. Discovery and fun. Stroll through historic sculptures, trails, and museums. Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

**Overall Responsibilities:** + The Clinical Research Coordinator, under the oversight of the Clinical Trial Manager and PI, is responsible for independently conducting clinical research sessions with study participants. + These sessions will be conducted on-site in South San Francisco and virtually. **Top 3 Daily Responsibilities:** + Conduct Clinical Research Coordinator activities for assigned clinical research device studies including consenting participants, conducting study sessions, maintaining device accountability, and completing data entry into the Electronic Data Capture (EDC) system. + Maintain Investigator Site Files and support Sponsor eTMF Maintenance. + Coordinate study participant recruitment efforts and ensure participants are compensated for their study participation. **Mandatory:** **Education:** + BS/BA degree in life science, health science, RN, or related field. + 3-5 years of professional working experience as a Clinical Research Coordinator. + Working knowledge of GCP and FDA Regulations. + Proficiency in MS Word, Excel PowerPoint, or Suite. + Experience utilizing Electronic Data Capture (EDC) systems for clinical studies. **Desired:** + Desired Experience with digital medical device research studies. + Experience maintaining an Electronic Trial Master File (eTMF). **Education:** + BS/BA degree in life science, health science, RN, or related field **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (*********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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

Palo Alto Veterans Institute for Research (PAVIR) is seeking a part-time Clinical Research Assistant - Yoga Instructor. The Clinical Research Assistant II - Yoga Instructor will support a research study evaluating yoga as a treatment for chronic musculoskeletal pain. The research is comparing online yoga for pain management delivered via a tablet/computer to participants at home ("teleyoga") as compared to online Acceptance and Commitment Therapy (ACT). The Clinical Research Assistant II - Yoga Instructor will deliver a yoga protocol online. The incumbent will work under the direction of the Project Manager and Yoga Supervisor. This a part-time, 10 hours/week, position, located in Palo Alto, CA. BENEFITS PAVIR is delighted to offer a robust and comprehensive employee benefits package with exceptional offerings such as sick pay policies, a 401(k) with a fully vested 6% company match and 3% profit share, commuter benefits, wellness program, employee assistance program, and professional development training. MAIN RESPONSIBILITIES: Yoga Intervention: Deliver teleyoga protocol for treating chronic pain; Instruct and educate participants in yoga techniques for treating chronic pain as described in the research protocol; Answer questions from participants; Other tasks as assigned. QUALIFICATIONS: Required: Bachelor's degree (or equivalent experience); Registered Yoga Alliance teacher. 500-hour level (Yoga Alliance RYT-500); 2 years or more of related experience; including instructing yoga techniques, 2-3 years of experience supporting research activities, particularly in health care; Desired: Experience working with a patient population with chronic health problems; Experience in therapeutic yoga; Experience working with veterans preferred but not necessary; Familiarity with standard concepts, practices, and procedures within the research field; Excellent interpersonal, verbal, and written communication skills; Strong public speaking skills; Strong organizational skills and ability to work independently. Knowledge of scientific writing; clearly, accurately, and engagingly conveying complex scientific, clinical and translational research; Excellent communication, organizational, and interpersonal skills will be necessary to facilitate the cooperation of the project team and to recruit the Veteran patients; Strong time management skills, ability to prioritize workload, organized, detail-oriented and dependable; Self-directed, able to work independently and provide the PI with regular project updates; General understanding of scientific theory and methods, experience with data analysis; Ability to work under deadlines with general guidance and as part of a team; Familiar with VA regulations and procedures regarding research; Experience in recruiting Veterans for research. ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR) PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research. READY TO JOIN OUR RESEARCH TEAM? If you feel that you would be right for this job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you! PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS and complete a background check before they can commence work. PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need special assistance or an accommodation to apply for a posted position, please contact ************** - Human Resources department.

**School of Medicine, Stanford, California, United States** Research Post Date Jun 10, 2025 Requisition # 106627 The Department of Neurology at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. **Duties include*:** + Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. + Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. + Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. + Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. + Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions. + Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. + Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. + Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - Other duties may also be assigned._ **DESIRED QUALIFICATIONS:** Prior certifications or experience preferred with administering various cognitive, neuropsychometric and functional assessments like MMSE, MoCA, RBANS, CDR, ADCS- ADL, ADAS-Cog ,Motor and non-motor evaluations and other assessments as per study requirements. **EDUCATION & EXPERIENCE (REQUIRED):** Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. **KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):** + Strong interpersonal skills. + Proficiency with Microsoft Office and database applications. + Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge of medical terminology. **CERTIFICATIONS & LICENSES:** Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License. **PHYSICAL REQUIREMENTS*:** + Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. + Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. + Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. _* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job._ **WORKING CONDITIONS:** + Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. + May require extended or unusual work hours based on research requirements and business needs. **WORK STANDARDS:** + Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. + Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. + Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,******************************* _The expected pay range for this position is $84,856 to $97,021 per annum._ _Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs._ _At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (***************************************************** provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process._ _Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting acontact form._ _Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law._ _The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned._ Additional Information + **Schedule: Full-time** + **Job Code: 4923** + **Employee Status: Regular** + **Grade: H** + **Requisition ID: 106627** + **Work Arrangement : On Site**

/RESPONSIBILITIES The Senior Clinical Research Coordinator leads the evaluation of research protocols and provides clinical and risk assessment expertise on research-related procedures. Assists Director in implementation of human subject research protection program. Reviews complex human subject research protocols and supports the Clinical Research Department through coordination, monitoring, and education of processes required for Research Proposals within University Health. Represents the department at multi-institutional committees and meetings, such as IRB and OHRP. EDUCATION/EXPERIENCE Graduation from an accredited college or university with a Bachelor's of Science in Nursing. May substitute 8 years of related experience and licensure for required education. Master's degree preferred. A minimum of three years Research experience required. Possesses or qualifies to obtain within 6 months of employment a Clinical Research Certification (i.e. CCRP or CCRA). Has a working knowledge of research methods and knowledge of federal legislation regarding human subject research is required. Expertise in applying for research protocols, budgeting, program planning and evaluation is preferred. Exercises mature judgment and discretion in any confidential or sensitive matters.

Company DescriptionJobs for Humanity is partnering with Stanford University to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located. Company Name: Stanford University Job Description The Division of Cardiovascular Medicine, within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease. We are seeking a Clinical Research Coordinator II (CRC-2) who is passionate about clinical research and wants to deliver results. The CRC-2 will report to the Clinical Research Manager and work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Associates and other stakeholders in support of the most advanced care for cardiovascular diseases. The successful applicant will have the ability to supervise clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes. CV Med Clinical Research is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine's mission. If you are eager to quickly achieve lasting results, we invite you to join our team! Duties include: Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS: Degree of certification in clinical research, public health or management. Expertise in project management. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong interpersonal skills. Proficiency in Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License. PHYSICAL REQUIREMENTS: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected]. For all other inquiries, please submit a contact form. WORKING STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************** The expected pay range for this position is $72,000 to $92,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved t

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

Palo Alto Veterans Institute for Research (PAVIR) is seeking a part-time Clinical Research Assistant - Acceptance and Commitment Therapy (ACT) Study Therapist. The CR Research Assistant - Acceptance and Commitment Therapy (ACT) Study Therapist will support a research study evaluating yoga as a treatment for chronic musculoskeletal pain. The research is comparing online yoga for pain management as compared to online Acceptance and Commitment Therapy (ACT). The Clinical Research Assistant / ACT Therapist will deliver the ACT protocol online. The incumbent will work under the direction of the Project Manager and ACT Supervisor. This a part-time, 20 hours/week, position, located in Palo Alto, CA. BENEFITS PAVIR is delighted to offer a robust and comprehensive employee benefits package with exceptional offerings such as sick pay policies, a 401(k) with a fully vested 6% company match and 3% profit share, commuter benefits, wellness program, employee assistance program, and professional development training. MAIN RESPONSIBILITIES: Undergo training in the Acceptance and Commitment Therapy (ACT) Protocol to include: Familiarizing and knowing the protocol safety and procedures. Following established safety protocols. Assist with delivery of ACT therapy according to protocol. Delivery of therapy via remote sessions. Recording sessions for rating. Assist with providing ACT to study participants Deliver ACT protocol for treating chronic pain. Collect information relevant to treatment. Assign homework to the study participants. Facilitate scheduling of sessions and evaluations. Collaborate with other researchers on the team. Assist with other study- related duties as needed. QUALIFICATIONS: Required: Bachelor's degree (or equivalent experience); 2+ years of related experience Experience conducting groups via video Experience performing a learning-based therapy (such as CBT or PST) Desired: Master's degree; Experience working with individuals with chronic pain conditions is strongly preferred; Familiarity with Acceptance and Commitment Therapy, Veterans, and the VA setting is preferred; Knowledge of VA and its health care system regarding clinical research trials preferred; Demonstrated ability to work independently and cooperatively. Excellent interpersonal, verbal, and written communication skills and good computer skills; Ability to read and understand the study protocol. Strong organizational skills and attention to detail. Proficiency in Microsoft Word, Outlook, and Excel; Ability to prioritize and organize workload and adapt to changing priorities. ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR) PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research. READY TO JOIN OUR RESEARCH TEAM? If you feel that you would be right for this job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you! PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS and complete a background check before they can commence work. PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need special assistance or an accommodation to apply for a posted position, please contact ************** - Human Resources department.

The Clinical Research Coordinator Associate is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and Clinics. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research. Responsibilities include preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advise the IRB of amendment changes to the protocol and complete annual protocol renewals. Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations. He/she participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment. Maintain drug accountability, adequate study supplies and equipment. The coordinator will oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject's medical record. Report all serious adverse events promptly to investigators, sponsors and the IRB. Protect the rights, safety and well-being of human subjects involved in the clinical trials. Duties include*: * Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. * Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. * Coordinate collection of study specimens and processing. * Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. * Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. * Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. * Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. * Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. * Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. * Participate in monitor visits and regulatory audits. * - Other duties may also be assigned. EDUCATION & EXPERIENCE (REQUIRED): Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): * Strong interpersonal skills. * Proficiency with Microsoft Office. * Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. PHYSICAL REQUIREMENTS*: * Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. * Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. * Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: Occasional evening and weekend hours. WORK STANDARDS: * Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. * Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. * Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************* The expected pay range for this position is $31.84 to $37.79 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (***************************************************** provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Additional Information * Schedule: Full-time * Job Code: 1013 * Employee Status: Regular * Grade: F * Requisition ID: 106623 * Work Arrangement : On Site

Company DescriptionJobs for Humanity is partnering with Stanford University to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located. Company Name: Stanford University Job Description The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health. At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply! In collaboration with the Division of Infectious Diseases and others at Stanford, SCCR is seeking 2 Clinical Research Coordinator Associates (CRCAs) to work on a highly impactful COVID-19 study, including but not limited to treatment trial for COVID-19. The CRCAs will work under a CRCII to recruit and enroll participants and monitor research participant workflow to ensure study visit completion. The CRCAs will coordinate all aspects of the study visits and work in a dynamic atmosphere and as part of a large team in a supportive environment. There will be the opportunity to work closely with fellow coordinators and research assistants, physicians, nurses, and technicians. Direct patient contact is a primary responsibility of these roles. The CRCAs are required to have the ability to multi-task in a high-energy environment. A flexible work schedule, outstanding communication and organizational skills, and attention to detail are required in successful candidates. The CRCAs will act as point of contacts for participants and staff, present at meetings and huddles, and troubleshoot research related issues. The CRCAs will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work under the direction of their supervisor/s. The CRCAs will work under close direction of the principal investigator and/or study coordinator/supervisor. Other duties may also be assigned. This is an on-site position. Duties include: Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS: Clinical research coordinator experience. Clinical research operations certificate or interest in working toward one. Valid CA driver's license. EDUCATION & EXPERIENCE (REQUIRED): Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Strong interpersonal skills. Proficiency with Microsoft Office. Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG. PHYSICAL REQUIREMENTS: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORKING STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************** The expected pay range for this position is $61,000 to $76,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with: Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. A caring culture. We provide superb retirement plans, generous time-off, and family care resources. A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. Discovery and fun. Stroll through historic sculptures, trails, and museums. Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orien

Palo Alto Veterans Institute for Research (PAVIR) supports the nation's second largest research program conducted among the VA Hospitals and is seeking a full-time Clinical Research Assistant - Health Educator. The Research Assistant - Health Educator will support several research studies aiming to improve Cancer Care for Veterans with Cancer. For all studies, the Research Assistant will be in direct contact with site leaders, oncology providers, and patients during data collection and intervention implementation activities. With assistance from the PI, Dr. Manali Patel, the Research Assistant will perform data collection, data entry, data management, simple data analysis, and creation of reports for funders as well as peer reviewed publications. This position will be 30-40 hours/week and is a 3-month, temporary position with the possibility of converting to a permanent/regular position depending on performance. BENEFITS PAVIR offers generous benefits, including comprehensive health insurance, vision, dental, sick pay, a 401(k) with a fully vested 6% company match and 3% profit share, a wellness program, commuter benefits, and professional development training. Plus, we pay for life, short-term disability, and long-term disability insurance. MAIN RESPONSIBILITIES: Serve as a primary contact with research participants, sponsors, and regulatory agencies. Assist with screening individuals for enrollment in the studies, determine eligibility, and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient data for clinical research projects. Assist with managing research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Help ensure compliance with research protocols, and review and audit case report forms on REDCap for completion and accuracy with source documents. Help to prepare regulatory submissions and ensure Institutional Review Board renewals and VA Research Review Committee renewals and applications are completed. Participate in monitor visits and regulatory audits. Ensure appropriate registration of trial information on clinicaltrials.gov and maintain renewals and updating information and uploading data upon study completion. Assemble study kits for study visits, monitor scheduling, coordinate documents, and attend monitoring meetings with sponsors and team members, acting as primary contact. Help monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Help prepare manuscripts and reports, including preparing tables and formatting references and assisting with grant applications. Assist with other study-related duties as needed. QUALIFICATIONS: Required: Bachelor's degree or equivalent experience; At least 1 year of relevant research experience (can be undergraduate experience); Preferred: Master's degree; Previous experience working in the VA system and/or experience with intervention trials in oncology, subject recruitment and screening; Understanding of statistics and familiarity with STATA or similar data analysis software; Strong interpersonal skills. Ability to communicate effectively with study participants and the research staff; Proficiency with Microsoft Office; Knowledge of medical terminology preferred; Organized, detail-oriented, self-directed, and dependable; Strong time management skills and ability to prioritize workload; Ability to work as part of a team; Able to learn VA regulations and procedures regarding research; General knowledge of research procedures gained through education or experience. ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR) PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research. READY TO JOIN OUR RESEARCH TEAM? If you feel that you would be right for this job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you! PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS and complete a background check before they can commence work. PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. If you need special assistance or an accommodation to apply for a posted position, please contact ************** - Human Resources department.