Clinical research associate jobs in Pleasanton, CA

Job Description Title: Clinical Research Associate - VahatiCor Status: Full-time, Exempt Reports to: Sr. Clinical Trials Manager - VahatiCor VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing solutions that improve patient outcomes. As our clinical program grows, we are building a dedicated clinical operations team to support early feasibility studies and future pivotal trials. The Clinical Research Associate will provide monitoring support, site engagement, documentation review, and operational assistance across all phases of our cardiovascular clinical studies. This role requires strong site management skills, attention to detail, and the ability to work effectively in a fast-moving environment. Experience in medtech is imperative. Responsibilities Site Monitoring & Study Execution · Conduct routine monitoring activities to ensure compliance with protocols, SOPs, FDA regulations, and ICH/GCP guidelines. · Support qualification, initiation, interim, and close-out visits (in-person and remote). · Perform source data verification, eCRF review, and assist with query resolution. · Build and maintain strong relationships with investigational sites to support enrollment and data quality. · Identify site-related issues and escalate appropriately. Documentation & Quality · Assist with the development and review of study documents, tools, and trackers. · Ensure timely and accurate TMF filing. · Support vendor oversight activities and quality checks. · Participate in audit and inspection-readiness activities. Cross-Functional Collaboration · Work closely with CTMs, CRAs, data management, and other clinical team members. · Support investigational product tracking and reconciliation activities. · Participate in team meetings and contribute to operational problem-solving. Required Experience & Qualifications · Bachelor's degree in the life sciences or a related field. · Minimum 2-4 years of experience as a CRA within the medtech industry; cardiovascular device experience preferred. · Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations. · Strong written and verbal communication skills. · Ability to travel up to approximately 50%. · Comfortable working in a dynamic, fast-paced environment. Eligibility Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas or permanent residency (PERM) applications. Location and Compensation This role is based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of California. There is no relocation package available. VahatiCor is committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package. Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired. The anticipated salary range of this position is $99,000 - $133,000 annually based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations. Equal Opportunity Statement VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. Third-Party Recruiter Notice We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor, and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email *******************.

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

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

Heluna Health invites applications for the full-time position of Research Study Coordinator in the Center on Substance Use & Health (CSUH), a grant-funded research unit within the San Francisco Department of Public Health (SFDPH). Research in this Unit focuses on the evaluation of behavioral, biological, and pharmacological clinical trials to reduce harms from substance use risk behaviors. Our close-knit team consists of a Medical Director, Senior Research Scientist, Research Study Coordinator, Research Clinicians, Clinical Psychologist, Research Associates and Recruitment Team. This is a temporary, grant-funded, Full time, benefitted position. Employment is provided by Heluna Health. Salary Range: $79,500-$87,500 annually Interested individuals must submit a cover letter and resume for consideration. Applications without a cover letter will not be considered. ESSENTIAL FUNCTIONS • Oversee and coordinate observational and intervention studies addressing substance use, including coordinating study start-up, ensuring that studies are enrolling according to goals; support staff to meet these goals using data-driven problem-solving • Oversee the development and implementation of standard operating procedures (SOPs) and study specific protocols (SSPs) and ensure adherence of study staff to protocols and the principles of Good Clinical Practice (GCP) • Oversee the development of study intervention materials such as qualitative interview guides, counseling manuals, etc. • Facilitate weekly meetings and supervise research associates and other staff working on studies; provide guidance as a supervisor, conduct regularly scheduled supervisory meetings with direct reports • Ensure that study staff are up-to-date with all training requirements, licenses and certifications • Oversee, plan for, manage, and problem-solve the data needs of the Unit including creating and modifying survey instruments, interview guides, and case report forms • Oversee and provide management of study databases, including activities such as chart abstractions from medical records • Create, oversee, and manage the quality control systems for research records, study data, and regulatory obligations • Recruit for and manage focus group sessions and qualitative interviews according to study protocols • Under the guidance of the CRPM, manage regulatory affairs of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Data Safety Monitoring Board, the Food and Drug Administration (FDA), and other funding or regulatory agency reports • Generate as-needed reports for study team, including reports on recruitment, enrollment, retention, and adverse events • Supervise and manage recruitment, contacting and building working relationships with primary providers in the community • Contribute to the coordination and writing of grants and manuscript submissions for the Unit • Plan for Unit staffing needs which may include hiring and training of research associates and clinical staff as needed • Perform other related duties as required JOB QUALIFICATIONS Education/Experience • Master's in Public Health or other relevant Master's level degree • 3+ years conducting/coordinating studies in public health, medical, substance abuse, or social services fields • Experience with qualitative research methods and analyzing qualitative data • Experience applying regulations and guidelines such as Good Clinical Practice Guidelines, Health Insurance Portability and Accountability Act (HIPAA), the Protection of Human Research Subjects, IRB regulations for recruitment and consent of research subjects • Experience writing detailed reports or IRB submissions • Experience supervising and managing research staff • Experience with diverse communities, particularly communities of color, LGBTQ, and substance using communities • Experience managing and analyzing data in Microsoft Access, Excel and/or Stata is a plus Other Skills, Knowledge, and Abilities • Proven high-level of attention to detail and ability to function independently and perform multiple critical tasks simultaneously under dynamic circumstances and competing deadlines • Familiarity with research processes including protocol development, recruitment, quantitative and qualitative research methods, data management, regulatory submissions, and quality assurance monitoring • Strong interpersonal and communication skills (both verbal and written) • Excellent organizational skills • Proficient computer skills including experience with Word, Excel, EndNote and PowerPoint • Proficiency in data management (REDCap, Excel, Atlas.ti) and/or computer coding experience • Knowledge of HIV prevention and harm reduction principles • Knowledge of federal and state laws, regulations, policies and procedures related to the protection of human subjects and confidentiality of research records • Phlebotomy certification PHYSICAL DEMANDS Stand Frequently Walk Frequently Sit Frequently Handling / Fingering Occasionally Reach Outward Occasionally Reach Above Shoulder Occasionally Climb, Crawl, Kneel, Bend Occasionally Lift / Carry Occasionally - Up to 50 lbs Push/Pull Occasionally - Up to 50 lbs See Constantly Taste/ Smell Not Applicable Not Applicable Not required for essential functions Occasionally (0 - 2 hrs/day) Frequently (2 - 5 hrs/day) Constantly (5+ hrs/day) WORK ENVIRONMENT General Office Setting, Indoors Temperature Controlled Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply. All qualified applicants will be considered for this position in accordance with the San Francisco Fair Chance Ordinance. EEOC STATEMENT It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants, without regard to age (40 and over), national origin or ancestry, race, color, religion, sex, gender, sexual orientation, pregnancy or perceived pregnancy, reproductive health decision making, physical or mental disability, medical condition (including cancer or a record or history of cancer), AIDS or HIV, genetic information or characteristics, veteran status or military service.

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 The Department of Anesthesiology, Perioperative and Pain Medicine, at Stanford University's School of Medicine, is a world-leading department that offers comprehensive training, perioperative patient care, pain management, and critical care medicine. The department also engages in cutting edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education. The Department of Anesthesiology, Pain and Perioperative Medicine at Stanford University is seeking a Clinical Research Coordinator Associate. The Clinical Research Coordinator will perform duties related to helping establish and coordinating moderately complex aspects of one or more clinical studies. The Clinical Research Coordinator will join a vibrant and innovative team committed to pediatric pain research under P.I., Dr. Jennifer Rabbitts. This lab includes multiple NIH funded research projects that collectively aim to address the impact of the pain and opioid epidemics on children, through identifying factors that contribute to development of chronic pain, and testing treatments to prevent chronic pain in children and adolescents. The Clinical Research Coordinator will work under close direction of the principal investigator and research supervisor/manager. At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health. Supporting that mission is a staff of more than 10,000, which is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers. School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, and postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department. For more information on our department, please see our website: **************************************** 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. Interact with lab members and collaborators to assist with other studies and tasks as needed. *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.

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.

**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.

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.

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

Grow your career at Cedars-Sinai! The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities: Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug. Maintains accurate source documents related to all research procedures. Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. Schedules and participates in monitoring and auditing activities. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications Educational, Certification, and Experience Requirements: High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred. SOCRA or ACRP Certification preferred upon hire One (1) year of clinical research related experience required About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents. About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most. Req ID : 12453 Working Title : Clinical Research Coordinator I - Emergency Dept Research - Full-Time, On-Site, Days Department : Research - ED Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies/ Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $23.39 - $39.76

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

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.

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 Stanford University's Skin Innovation and Interventional Research Group (SIIRG) in the Department of Dermatology is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or manager/supervisor. The CRCA will support federal and non-federal clinical research studies including dermatological and investigative work in support of clinical trials, clinical research or biomedical research focusing on “bench to bedside” treatment. 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 DESIRED QUALIFICATIONS: A Bachelor's degree with an educational background in medicine and/or scientific field (biological sciences, social sciences, etc.) Strong oral and written communication skills. Excellent attention to detail. Proficiency in using computers, software, and web-based applications in a previous administrative setting. 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 $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.

Job Description 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. Job Posted by ApplicantPro