Clinical Director ACESClinical DirectorPittsburg, CA$105,000–$110,000 / yearDeveloping and monitoring SV cases loads and capacity: Update SV Capacity sheet, assisting in monitoring credentialing, assigning distribution of caseload by time of day, region, qualifications, facilitating case transfers as needed, communicate SV needs to Recruiting. Working under the supervision of the Regional Director and in concert with department heads and the executive team, essential job responsibilities include, but are not limited to: Utilization Management: Conduct Daily and weekly reviews and problem solving with supervisors of client utilization for collective office and at individual client level.
NewLead Site Clinical Research Coordinator Salma Health IncLead Site Clinical Research CoordinatorFremont, CA$72,203–$100,000 / yearThe Lead Site Clinical Research Coordinator (CRC) is the founding coordinator for Salma Healths Fremont clinic, responsible for establishing research operations at the site and managing day-to-day study conduct, including the ATLAS study and sponsored trials. The CRC may also support regulatory submissions across Salma Health trials, including the La Jolla and Laguna Hills sites, and serves as the primary point of contact for sponsors, the IRB, and research participants.
NewDirector, Clinical Research Scientist Taiho OncologyDirector, Clinical Research ScientistPleasanton, CA$238,000–$280,000 / yearFull timeThe Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, and assisting the Clinical Research Scientist Manager to contribute to CRS process improvement, as needed. . If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Senior Manager, Clinical Consulting - Clinical Informatics Kaiser PermanenteSenior Manager, Clinical Consulting - Clinical InformaticsPleasanton, CAManages a team of consultants to ensure the alignment, buy-in, and coordination of diverse stakeholders to drive successful initiatives and projects within care delivery or clinical settings across one or more technical areas or workstreams by making significant contributions and/or providing leadership to high visibility projects to identify and resolve issues of strategic importance to the organization; identifying and ensuring representation and inclusion of appropriate stakeholders and team members; building rapport and partnerships with stakeholder teams, third party vendors, and senior/executive management to produce results that are outcome driven; working with stakeholders to set the strategic direction of initiatives, develop goals and set the prioritization of deliverables; discussing involvement of key processes (e.g. Manages complex, highly visible projects or project components by partnering with clinical leadership and key stakeholders; providing guidance on assembling teams based on project needs and team member strengths; overseeing the development, analysis, and management of project plans, including proposed project structure, approach and work plan; negotiating time commitments and resources; coordinating project schedules and resource forecasts; proactively monitoring, identifying, and resolving project or clinical initiative risks, issues, and trigger events; developing mitigation plans and strategies; resolving or escalating risks or issues as appropriate; and providing leadership advice to project teams, as well as managing the work of outside consultants when needed.
Sr. Clinical Research Associate Intuitive Surgical IncSr. Clinical Research AssociateSunnyvale, CAAssist with the development and management of study electronic clinical trial master file (eTMF) and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.). Co-Management of site start-up/activation process, including heavy contribution to the preparation of study-related documents and complete checklists, able to help with clinical trial agreements and budget negotiation, finalization of clinical monitoring plan, training materials, etc.
Senior Clinical Study Manager Intuitive Surgical IncSenior Clinical Study ManagerSunnyvale, CAResponsible for the planning and execution of the clinical studies including site selection, analysis of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful progress. The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or support the development of clinical publications.
NewAssociate Director, Clinical Affairs Becton Dickinson Medical DevicesAssociate Director, Clinical AffairsMilpitas, CaliforniaWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. · Industry-Specific Experience: Experience supporting clinical studies for in vitro diagnostics (IVD), molecular diagnostics, genomics, proteomics, life science research tools, or related technologies—this is particularly important given the Waters Biosciences business focus.
Sr. Manager Clinical Research Engineering Intuitive SurgicalSr. Manager Clinical Research EngineeringSunnyvale, CAHire, develop and mentor CREs for the program, Presents findings to key opinion leaders, subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design and development of new platforms, procedures, instruments, and accessories. Manager Clinical Research Engineering uses their in-depth clinical, scientific, and technical knowledge to lead, collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts being incubated in early exploration.
Clinical Research Coordinator Yowei TherapeuticsClinical Research CoordinatorMilpitas, CA$80,000–$100,000 / yearIn 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities.
Sr Mgr, Project Management- AI Clinical Research Kaiser PermanenteSr Mgr, Project Management- AI Clinical ResearchPleasanton, CAManages designated units or teams by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed; partners with key stakeholders and business leaders to ensure products and / or services meet requirements and expectations while aligning with departmental strategies. Manages the alignment, buy-in, engagement and support of diverse project stakeholders by building and maintaining relationships as well as communicating appropriately with internal customers, third party vendors, senior and/or executive management, and business leaders; and clarifying accountability and authority across stakeholders.
Clinical Research Associate 3 Intuitive SurgicalClinical Research Associate 3Sunnyvale, CAThe candidate will be required to work closely with clinical study managers, clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, contribute to clinical study reports, or help the development of clinical publications. Manage site start-up/activation process, including: Heavy contribution to the preparation of study-related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, able to help clinical trial agreements and budget negotiation, clinical monitoring plan).
Clinical Operations Manager Yowei TherapeuticsClinical Operations ManagerMilpitas, CA$150,000–$170,000 / yearReporting to the Chief Medical Officer, this person will translate clinical strategy and protocols into practical operating plans, lead study and site start-up, coordinate sites and vendors, manage timelines and budgets, and ensure consistent execution from feasibility through closeout. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production.
Clinical Research Coordinator Flourish ResearchClinical Research CoordinatorWalnut Creek, CaliforniaFlourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources.
Senior Manager Clinical Affairs Intuitive SurgicalSenior Manager Clinical AffairsSunnyvale, CAThis role will oversee and manages clinical protocols and other key study documents in support of regulatory submissions; manage clinical publications and evidence dissemination strategy, oversee manage communications with clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage team to interface and support all clinical requirements of the company with the applicable guidelines and regulations; foresee challenges and develops critical concepts and methodologies to overcome those. As a key cross-functional constituent, this employee will work closely with functions across the organization - Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives.
Senior Clinical Research Associate Protagonist Therapeutics IncSenior Clinical Research AssociateNewark, CA$135,000–$150,000 / yearSupport study vendor management by performing key activities as delegated by study CTM, including but not limited to: Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors • Manage the day to day interactions with select study vendor(s), such as a central or specialty lab including developing training materials, lab manuals and acting as first point of contact for issue and query escalation and resolution. Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to: Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •.
On-site Clinical Research Associate Protagonist Therapeutics IncOn-site Clinical Research AssociateNewark, CA$125,000–$135,000 / yearThe Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.
Clinical Research Assistant- Modesto Retina Sacramento MSO LLCClinical Research Assistant- ModestoModesto, CAFull timeAlthough 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. 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.
Clinical Research Coordinator- Modesto Retina Sacramento MSO LLCClinical Research Coordinator- ModestoModesto, CAFull timeOversees data and ensures that it is being entered correctly and resolves any queries issued within required timeframeCollects and reports ALL Adverse EventsCollects and reports ALL Serious Adverse EventsResponsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewedCoordinates monitor site visits and assists with preparation of site visit documentationWorks with the monitor to make any corrections needed to meet requirements and deadlines as neededCollects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required timeframeManages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor. 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.
Clinical Flow Cytometry Account Manager – South Texas Becton Dickinson Medical DevicesClinical Flow Cytometry Account Manager – South TexasMilpitas, CaliforniaRemoteAs part of the Waters Biosciences Commercial team, drive sustainable territory growth by developing new business opportunities, expanding strategic clinical accounts, and advancing customer adoption of Waters solutions across clinical and diagnostic testing environments. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance.
Clinical Site Manager (Oncology) F. Hoffmann-La Roche LtdClinical Site Manager (Oncology)Pleasanton, CA$90,900–$150,480 / yearWorking in local and global study teams, including virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross-functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence. Developing and managing key study site documentation, such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms, while contributing technical expertise to review study protocols, data management plans, reports, and manuscripts.