NewDirector of Clinical FP&A Vaco LLCDirector of Clinical FP&APalo Alto, CA$225,000–$255,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors, including but not limited to: The individual’s skill sets, experience, and training; Licensure and certifications; Office location and other geographic considerations; Other business and organizational needs.
Sr Clinical Solution Specialist Medline IndustriesSr Clinical Solution SpecialistSan Francisco, CA$79,000–$119,000 / yearFull timeThe position would require the ability to provide end user insight to urology process enhancement and improvement opportunities, link clinical practice with products and programs, and build strategic alliances with customers and sales representatives as it relates to executing successful value add programs. Our Medline Acute Care team serves as the main interface for various segments in the hospital such as OR, Cath Lab, ICU, Labor and Delivery, Emergency Department, Materials Management and C-suite.
NewIT Consultant IV, Solutions - SNOMED CT, Clinical Coding, Epic, EHR, Informatics Kaiser PermanenteIT Consultant IV, Solutions - SNOMED CT, Clinical Coding, Epic, EHR, InformaticsPleasanton, CA$129,200Essential Responsibilities: Completes work assignments and supports business-specific projects by applying expertise in subject area; supporting the development of work plans to meet business priorities and deadlines; ensuring team follows all procedures and policies; coordinating and assigning resources to accomplish priorities and deadlines; collaborating cross-functionally to make effective business decisions; solving complex problems; escalating high priority issues or risks, as appropriate; and recognizing and capitalizing on improvement opportunities. Ability and/or having the capacity to learn -knowledge representation- logic to create, maintain subsets of clinical records to support reporting, business intelligence in the areas of best practice alerts, population and healthcare management, quality measurements, and health information exchanges.
Medical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentSan Francisco, CA$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Manager, GMP Quality Assurance - Clinical, QA - Remote Agios PharmaceuticalsManager, GMP Quality Assurance - Clinical, QA - RemoteSan Francisco, CARemote$110,029–$165,044 / yearThe current base salary range for this position is expected to be between $110,029 and $165,044 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Manager, GMP Quality Assurance, Clinical will be responsible for responsible for supporting and maintaining high quality levels on Agios Drug Substance and Drug Product by Contract Manufacturing Organizations (CMOs).
Senior Manager, Clinical Educator, Sickle Cell Disease - Remote Agios PharmaceuticalsSenior Manager, Clinical Educator, Sickle Cell Disease - RemoteSan Francisco, CARemote$131,035–$196,553 / yearThe current base salary range for this position is expected to be between $131,035 and $196,553 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The ACE will also gain insights from clinical teams and office staff supporting patients with sickle cell disease to further their understanding of the disease burden associated with sickle cell disease and the types of support they need for their patients.
Senior Manager, Clinical Nurse Educator – Sickle Cell Disease - Remote Agios PharmaceuticalsSenior Manager, Clinical Nurse Educator – Sickle Cell Disease - RemoteSan Francisco, CARemote$127,219–$190,828 / yearBuilding on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives.
Associate Director, Clinical Educator, Sickle Cell Disease (West Zone) - Remote Agios PharmaceuticalsAssociate Director, Clinical Educator, Sickle Cell Disease (West Zone) - RemoteSan Francisco, CARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Regional Agios Clinical Educator Manager is a unique leadership opportunity, providing day to day oversight of 5-7 Agios Clinical Educators (ACEs) who interact directly with patients and healthcare professionals.
Associate Director, Clinical Educator, Sickle Cell Disease (East Zone) - Remote Agios PharmaceuticalsAssociate Director, Clinical Educator, Sickle Cell Disease (East Zone) - RemoteSan Francisco, CARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Regional Agios Clinical Educator Manager is a unique leadership opportunity, providing day to day oversight of 5-7 Agios Clinical Educators (ACEs) who interact directly with patients and healthcare professionals.
NewClinical Coordinator (RN) Satellite Holdings, LLCClinical Coordinator (RN)Oakland, CA$104,772.83–$130,667.51Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations.
Senior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsSan Francisco, CAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
Clinical Research Manager UCSF Medical CenterClinical Research ManagerSan Francisco, CAThe Clinical Research Manager will work closely with senior management, including Principal Investigators, the Program Director, and Department leadership, to develop long and short term strategies to carryout the goal of developing effective treatments for Alzheimer's Disease, Progressive Supranuclear Palsy, Frontotemporal Dementia and other related disorders. To further engage in this work, the center collaborates with organizations such as the Alzheimer's Disease Research Center (ADRC), Bluefield Project to Cure Frontotemporal Dementia, California Alzheimer's Disease Center, Global Brain Health Institute, and the Tau Consortium.
Per Diem Clinical Research Nurse - Home Visits Science 37 IncPer Diem Clinical Research Nurse - Home VisitsSan Bruno, CA$50–$55 / hourWith interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials.
NewClinical Research Coordinator to Home-Based CRA (Clinical Research Associate) Medpace, Inc.Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)San Francisco, CaliforniaRemoteResponsibilities: Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and. Qualifications: Must have a minimum of a Bachelor’s degree in a health or science related field; Experience as a Clinical Research Coordinator (minimum 1 year); Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely; Must maintain a valid driver’s license and the ability to drive to monitoring sites; Proficient knowledge of Microsoft® Office; Strong communication and presentation skills; and.
Clinical Research Manager - Heme Malignancy Program UCSF Medical CenterClinical Research Manager - Heme Malignancy ProgramSan Francisco, CAThe candidate will have leadership skills and training experience to provide operational leadership to a group of Clinical Research Staff, including Clinical Research Supervisor(s), Senior Clinical Research Coordinator(s), Clinical Research Coordinators and Assistant Clinical Research Coordinator(s) (total program size of ~ 14 staff), while monitoring workload and productivity. Under the direction of the Associate Director, the Clinical Research Manager is responsible for strategic planning in order to meet program goals, along with ensuring all reporting and study milestones are met including recruitment targets, data entry timelines, budget and sponsor requirements.
Clinical Research Coordinator UCSF Medical CenterClinical Research CoordinatorSan Francisco, CAThe duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; recruit study participants; act as intermediary between services and departments while overseeing data management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; manage Investigator's protocols in the IRB/Institutional Review Board online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. Department Description: The UCSF Division of General Internal Medicine (DGIM) at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) delivers innovative, comprehensive and complex primary medical care to San Francisco's vulnerable patients; carries out highly impactful translational research focused on generating new knowledge to improve the health of vulnerable populations; engages in meaningful policy work focused on reducing health disparities and ensuring access to care; and trains the next generation of physician leaders and researchers in the care of vulnerable and underserved populations.
Manager, Clinical Research Cutera IncManager, Clinical ResearchBrisbane, CADuties & Responsibilities: Lead the development and management of clinical study documentation, including protocols, case report forms (paper and electronic), informed consent forms, subject questionnaires, clinical study reports, statistical analysis plans, and regulatory submissions. Position Summary: The Manager, Clinical Research reports to the Director, Clinical Research and is responsible for leading and managing clinical research activities with participating study physicians and research sites.
Senior Clinical Research Associate (level dependent on experience) CTISenior Clinical Research Associate (level dependent on experience)San Francisco, CaliforniaFor that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward. To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance.
Clinical Research Coordinator Associate Stanford UniversityClinical Research Coordinator AssociateRedwood City, CA$34.56–$40.30 / hourStanford University's 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 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.
Senior Clinical Research Associate Epicrispr Biotechnologies IncSenior Clinical Research AssociateSouth San Francisco, CA$115,000–$121,000 / yearSupport clinical trial manager with site management, including: site startup activities, co-monitoring visits alongside CRO, reviewing monitoring visit reports, coordinating vendor trainings, reviewing study newsletters, and other duties as needed, in alignment with study priorities and CTM guidance. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.
Clinical Research Coordinator - Early Phase Program UCSF Medical CenterClinical Research Coordinator - Early Phase ProgramSan Francisco, CAThis involves coordinating study required procedures and treatments for study patients; managing and updating databases to insure data integrity; acting as intermediary between sponsors, research staff, and various UCSF departments; assuring compliance with all relevant regulatory agencies; assisting Clinical Research Manager, Associate Director of Clinical Research Programs and/or PI with research tasks; maintaining relevant regulatory documents in partnership with the Regulatory department; reporting study progress to investigators; participating in any internal and external audits or reviews of study protocols; and performing other duties as assigned. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
Assistant Clinical Research Coordinator UCSF Medical CenterAssistant Clinical Research CoordinatorSan Francisco, CAMay be responsible for the coordination of one or more single or multi-site, active or follow-up clinical trials; help prepare protocols for study initiation; help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial subjects; may apply understanding of inclusion/exclusion eligibility criteria for protocols; help recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and assure collection and shipment of samples; assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned. Abstracts clinical data from medical records; enters data onto case report forms, study flow sheets, and other forms; submits required data and data forms in accordance with accuracy and timeliness requirements of the protocols; addresses and resolves data queries; identifies, investigates and resolves data quality issues.
Senior Clinical Program Manager, Clinical Operations Revolution MedicinesSenior Clinical Program Manager, Clinical OperationsRedwood City, CaliforniaThe company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
Senior Clinical Program Manager, Clinical Operations Revolution Medicines IncSenior Clinical Program Manager, Clinical OperationsRedwood City, CA$164,000–$205,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
Clinical Research Supervisor UCSF Medical CenterClinical Research SupervisorSan Francisco, CATrains, supervises, and guide CRCs to prepare for monitoring and audit visits, including ensuring all study documents are complete, organized, and current, all data is submitted and queries answered, and all action items from prior visits are completed. Provides excellent judgment and initiative to ensure procedures are properly billed to optimize patient care and use of limited resources, may assist Clinical Research Manager in creating systems to ensure these operations are properly.
Per Diem Clinical Research Nurse - Home Visits Science 37Per Diem Clinical Research Nurse - Home VisitsSan Bruno, CA$50–$55 / hourWith interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials.
NewAssociate Director, Clinical Data Management, Hybrid Merck & Co IncAssociate Director, Clinical Data Management, HybridSouth San Francisco, CA$142,400–$224,100 / yearor B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes -OR-. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.
Sr. Clinical Research Associate CareDx IncSr. Clinical Research AssociateBrisbane, CARemote$100,000–$130,000 / yearCareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
Associate Principal Scientist, Clinical Research Merck & Co IncAssociate Principal Scientist, Clinical ResearchSouth San Francisco, CA$142,400–$224,100 / yearTranslational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. Leads and directs teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross-functional governance meetings, and advisory meeting preparation.
Manager of Clinical Research, AQMed SB Technology IncManager of Clinical Research, AQMedPalo Alto, CADemonstrated success leading multi-center clinical trials across multiple geographies, including site management, IRB/EC submissions, and regulatory coordination. Develop and maintain clinical study plans, protocols, budgets, agreements, timelines; proactively identify and resolve threats to enrollment, data quality, and regulatory timelines.
Principal Scientist, Clinical Research - Immunology/Dermatology Merck & Co IncPrincipal Scientist, Clinical Research - Immunology/DermatologySouth San Francisco, CA$255,800–$402,700 / yearAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
Senior Director, Clinical and Translational Research Omada Health IncSenior Director, Clinical and Translational ResearchCA$243,800–$304,800 / yearLead the development and interpretation of health economics and outcomes research (HEOR), including cost-effectiveness, budget impact, and total cost of care analyses that clearly articulate value to Medicare Advantage plans, commercial employers, and provider partners. Deep expertise in health economics and outcomes research (HEOR), including hands-on and/or leadership experience with healthcare claims analysis, cost and utilization modeling, and total cost of care analyses for Medicare Advantage and commercial employer populations.
Senior Manager, Clinical Data Management Mirum PharmaceuticalsSenior Manager, Clinical Data ManagementFoster City, CaliforniaReviews and approves DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, Validation Plan, User Acceptance Testing (UAT) documentation, Data Review Plan, etc. clinical study protocols, protocol deviation plans, medical monitoring plan, statistical analysis plan, mock Tables, Figures and Listings (TFL) shells and Clinical Study Reports (CSRs).
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) •.
NewClinical Reseach Coordinator UCSF Medical CenterClinical Reseach CoordinatorSan Francisco, CAIncumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Manager and/or PI with oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
NewRegional Clinical Operations Manager JumpstartMDRegional Clinical Operations ManagerBurlingame, CaliforniaWe are seeking an individual with a proven track record in multi-site operations leadership, a deep commitment to exceptional member experience, and the leadership instincts to develop and inspire Clinician Managers across our Bay Area region. Are you an experienced operations leader with a passion for healthcare and wellness — someone who thrives in a fast-paced, multi-site environment and knows how to develop great managers, drive results through data, and create a culture of accountability and excellence?
Clinical Research Associate / Senior Clinical Research Associate CareTechProsClinical Research Associate / Senior Clinical Research AssociateSan Francisco, CaliforniaWe are looking for a Clinical Research Associate to manage clinical trial activities from initiation to closeout. The ideal candidate is organized, detail-oriented, and experienced in managing complex clinical trials.
NewManager, Clinical Supply Chain Mirum PharmaceuticalsManager, Clinical Supply ChainFoster City, CaliforniaReporting to the Executive Director, Clinical Supply Chain, the Manager is responsible for the global supply and distribution of investigational drug productfor Mirum’s ongoing clinical trials inclusive of the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. Supports the preparation and review of Mirum documentation including regulatory applications, clinical trial applications, routine amendments, protocols, briefing documents, Quality Technical Agreements, responses to health authority inquiries, and other documents as required.
Manager, Clinical Lab Management Nektar TherapeuticsManager, Clinical Lab ManagementCA$150,000–$185,000 / yearNektar currently anticipates the base salary for the Manager, Clinical Data Management to range from $150,000 to $185,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience. This role ensures the timely delivery of high-quality biological samples used to evaluate drug efficacy and is an integral member of the study team across study start-up, conduct, and close-out.
Clinical Research Assistant – Dementia and Aging PAVIRClinical Research Assistant – Dementia and AgingPalo Alto, CAFull timeMonitor recruitment of study subjects, data completion, and protocol deviations; Prepare regular progress reports on these matters and propose and implement strategies to keep team on target, with input from the principal investigator as needed; Schedule sessions, help with obtaining written informed consent, and run participants through their respective protocols; Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements; Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms; Conduct quality assessment of data in project redcap database. Coordinate community educational outreach events about dementia and aging in English and/or Spanish; Foster community relationships; Assist in creating outreach materials and utilize materials created by Principal Investigator (PI) and the team to conduct small educational events to increase dementia awareness in the community; Interview community participants to identify their educational needs; Assist the PI and the team to create educational materials based on community needs analyses.
Senior Clinical Research Scientist II Caribou Biosciences, Inc.Senior Clinical Research Scientist IIBerkeley, CA$215,000–$230,000 / yearWe believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases.
Vice President, Clinical Development Oncology & Molecular Diagnostics Natera IncVice President, Clinical Development Oncology & Molecular DiagnosticsCA$350,000–$430,000 / yearThis is a high-autonomy role for a builder who can navigate rapid structural transitions-specifically our evolution from a Laboratory Developed Test (LDT) framework into highly regulated FDA In Vitro Diagnostic (IVD) and Companion Diagnostic (CDx) pharma partnerships. This corporate leader will institutionalize clinical trial architecture across the enterprise, distinct from therapeutic area strategy, with an immediate focus on defending and expanding our oncology footprint (including Early Cancer Detection and Signatera MRD), alongside corporate-level support for Women''s Health and Organ Health.
NewSenior Director, Clinical Portfolio and Program Management Allogene TherapeuticsSenior Director, Clinical Portfolio and Program ManagementSouth San Francisco, CARemote$230,000–$270,000 / yearWork with the program team members to facilitate project/program execution from Pre-IND planning through BLA/MAA approvals utilizing project management tools and processes to maintain strategic direction, project schedule/timeline, communications, budget/cost and identify and mitigate risks. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
Senior Director, Clinical Portfolio and Program Management Allogene Therapeutics IncSenior Director, Clinical Portfolio and Program ManagementSouth San Francisco, CA$230,000–$270,000 / yearWork with the program team members to facilitate project/program execution from Pre-IND planning through BLA/MAA approvals utilizing project management tools and processes to maintain strategic direction, project schedule/timeline, communications, budget/cost and identify and mitigate risks. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
NewLimited Appointment Senior Clinical Research Coordinator UCSF Medical CenterLimited Appointment Senior Clinical Research CoordinatorOakland, CAReporting to the Clinical Research Supervisor, the Senior CRC's duties may include: central responsibility for ensuring IRB approval and compliance, budget and contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial, oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes; coordinate staff work schedules and assist the Clinical Research Supervisor and/or PI with oversight and training of other research staff; manage Investigator's protocols in the IRB online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff administration, IRB, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
Clinical Research Coordinator Surgery UCSF Medical CenterClinical Research Coordinator SurgerySan Francisco, CAKnowledge of UCSF and departmental policies for dealing with research payments and reimbursements; patient safety and confidentiality; packing/shipping infectious substances; database building/analysis, and data management within some of the following platforms: Access, Stata, SASS/ SPSS, and Teleform. Experience applying the following regulations and guidelines:The Protection of Human Research SubjectsGood Clinical PracticeHealth Insurance Portability and Accountability Act (HIPAA)IRB regulationsSafe shipping practices (IATA)Environmental Health and Safety TrainingFire Safety Training.
Senior Clinical Research Coordinator, Liver Biorepository UCSF Medical CenterSenior Clinical Research Coordinator, Liver BiorepositorySan Francisco, CAReporting to the Principal Investigator/Director, the incumbent has central responsibility for ensuring IRB approval and ongoing compliance for the biorepository and its protocols; managing consent, specimen accessioning, inventory, and chain-of-custody; coordinating biospecimen requests and material transfers; and building and maintaining the IELB website to communicate available samples, governance policies, and request procedures to the research community. Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
Clinical Trials Manager (Biotechnology, Oncology) Exelixis IncClinical Trials Manager (Biotechnology, Oncology)Alameda, CA$136,000–$192,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or, MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or, PhD/PharmD in biological sciences or related field and zero or more years of related experience; or, Equivalent combination of education and experience. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).
Payer STARS/Quality Clinical Consultant, Senior Manager PricewaterhouseCoopers LLPPayer STARS/Quality Clinical Consultant, Senior ManagerSan Francisco, CA$124,000–$280,000 / yearAs a Payer STARS/Quality Clinical Consultant, Senior Manager, you will engage with clients in the health services sector, providing strategic guidance and operational consulting to enhance their clinical quality and performance metrics. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.