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.
NewLicensed Clinical Social Worker Oncology Kaiser PermanenteLicensed Clinical Social Worker OncologySanta Clara, CAMay supervise Post Masters Fellows, Associate Clinical Social Workers, Associate Marriage Family Therapists or Associate Professional Clinical Counselors as needed if supervision course is completed. Utilizes resources of public and private agencies and community organizations to meet the needs of the members treatment to include referral of the member and/or members family to external resources, as appropriate.
NewLicensed Clinical Social Worker NonEx Pediatric Palliative Care Kaiser PermanenteLicensed Clinical Social Worker NonEx Pediatric Palliative CareSanta Clara, CAMay supervise Post Masters Fellows, Associate Clinical Social Workers, Associate Marriage Family Therapists or Associate Professional Clinical Counselors as needed if supervision course is completed. Utilizes resources of public and private agencies and community organizations to meet the needs of the members treatment to include referral of the member and/or members family to external resources, as appropriate.
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 Jose, 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 Manager Stanford UniversityClinical Research ManagerStanford, CA$124,521–$153,615 / yearThe 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. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
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 Trial Manager Imperative CareClinical Trial ManagerCampbell, CaliforniaImperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. Contribute operational expertise to the development of study protocols, clinical study documents, and cross-functional clinical initiatives that support innovative neurovascular medical device programs.
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 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.
NewCancer Clinical Research Coordinator 2 - Melanoma (Hybrid) Stanford UniversityCancer Clinical Research Coordinator 2 - Melanoma (Hybrid)Stanford, CA$86,248–$100,158 / yearStanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments for our Melanoma Clinical Research Group (CRG)Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. 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 (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.
Cancer Clinical Research Coordinator Associate - GI (Onsite) Stanford UniversityCancer Clinical Research Coordinator Associate - GI (Onsite)Stanford, CA$34.56–$40.30 / hourThe 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. The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine.
Cancer Clinical Research Coordinator 2 - BMT (Hybrid) Stanford UniversityCancer Clinical Research Coordinator 2 - BMT (Hybrid)Stanford, CA$86,248–$100,158 / yearThe 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. Reporting to Clinical Research Manager of Blood and Marrow Transplantation and Cell Therapy (BMT-CT), the Clinical Research Coordinator 2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to Clinical Research Coordinator 2 High Level Duties.
Cancer Clinical Research Coordinator 2 - Gastrointestinal (GI) (Hybrid) Stanford UniversityCancer Clinical Research Coordinator 2 - Gastrointestinal (GI) (Hybrid)Stanford, CA$86,248–$101,158 / yearThe 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. The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country and is a prominent dynamic growing and complex Institute within the Stanford University School of Medicine.
NewClinical Research Coordinator 2 Stanford UniversityClinical Research Coordinator 2Stanford, CA$86,248–$100,158 / yearThe 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. The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees.
NewClinical 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.
Clinical Research Coordinator 2 (Fixed-term 2 years) Stanford UniversityClinical Research Coordinator 2 (Fixed-term 2 years)Stanford, CA$86,248–$100,158 / yearThe Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University is seeking a Clinical Research Coordinator 2 (Fixed-term 2 years) to serve as the operational program manager for a multi-PI, federally funded clinical research program, and to independently manage all aspects of complex, multi-trial clinical research coordination. 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.
Patient Care Manager (RN), Cancer Clinical Research Stanford Health CarePatient Care Manager (RN), Cancer Clinical ResearchPALO ALTO, CA$89.01–$117.94 / hourClinical Practice: Ensures the effective delivery of competent, compassionate, and efficient patient care by planning, organizing, and directing the nursing services of unit(s), including the assessment of patients, implementation of physicians' orders, treatment plans and medical procedures, administration of medication and record keeping of same as well as by monitoring and evaluating patient care processes and outcomes for the patient care unit(s); coordinates nursing activities with those of other services or disciplines. The Patient Care Manager is a Registered Nurse who provides unit leadership and works in partnership with nursing, the healthcare team, hospital/system leaders to develop a quality practice setting that support professional nursing and quality patient care.
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.
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.
Clinical Research Coordinator Associate (2-Year Fixed Term) Stanford UniversityClinical Research Coordinator Associate (2-Year Fixed Term)Stanford, CA$34.56–$40.30 / hourThe Department of Psychiatry and Behavioral Sciences at Stanford Universitys School of Medicine is looking for an organized and motivated individual to fill the role of Clinical Research Coordinator Associate (CRCA) to coordinate aspects of a study focusing on fertility and family building in young adult female cancer survivors. 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.
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.
NewAssistant Clinical Research Coordinator Stanford UniversityAssistant Clinical Research CoordinatorStanford, CACorrespond with the Institution Review Board and the SCI Clinical Trials Office in order to open, close, and renew research studies, register new patients consented for clinical studies, and assist adverse event and case report forms. This is a unique opportunity to receive mentorship from faculty on the cutting edge of radiation oncology, work closely with research teams to produce world-class clinical research, and gain insight into academic medicine.
Clinical Research Coordinator Associate, General Surgery (Hybrid Opportunity) Stanford UniversityClinical Research Coordinator Associate, General Surgery (Hybrid Opportunity)Stanford, CA$34.56–$40.30 / hourThe 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. 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.
Clinical Research Coordinator Stanford UniversityClinical Research CoordinatorStanford, CA$34.56–$40.30 / hourThe candidate will work on multiple on-going projects within the lab, including Gait Assessment in Alzheimer's and Mild Cognitive Impairment in collaboration with Stanford Alzheimer's Research Center (ADRC), Understanding Neuropsychiatric Symptoms in older adults, Applications of AI and Large Language Models (LLMs) in psychiatry and mental health, and others. 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.
Clinical Research Coordinator Associate (18 Month Fixed Term) Stanford UniversityClinical Research Coordinator Associate (18 Month Fixed Term)Stanford, CA$34.56–$40.30 / hourThe Stanford University Department of Orthopaedic Surgery in the Division of Pediatric Orthopaedic Surgery is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of various clinical studies and data-driven projects related to spinal surgery and scoliosis outcomes. 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.
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.
Digital Decision Aid Clinical Research Coordinator 2 (Hybrid Opportunity) (2-Year Fixed-Term) Stanford UniversityDigital Decision Aid Clinical Research Coordinator 2 (Hybrid Opportunity) (2-Year Fixed-Term)Stanford, CA$86,248–$100,158 / yearDr. Stafford and his co-investigators seek an experienced and enthusiastic Clinical Research Coordinator 2 to join a multidisciplinary team conducting an NIH-funded clinical trial testing the effectiveness of a digital decision-making app in older people with advanced heart failure considering placement of an implantable cardioverter-defibrillator (ICD). 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.
Clinical Research Coordinator 2 Apidel TechnologiesClinical Research Coordinator 2Stanford, CAContractorFormally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. 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.
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.
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.
Clinical Research Associate II Imperative CareClinical Research Associate IICampbell, CaliforniaThe Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Provide in-house clinical operations support by assisting with study documentation, site coordination, and day-to-day clinical trial activities to help ensure successful study execution.
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) •.
Manager, Clinical Research Engineering Intuitive Surgical IncManager, Clinical Research EngineeringSunnyvale, CALeveraging deep clinical, scientific, and engineering expertise, this role will partner with engineers, physicians, interaction designers, human factors specialists, training teams, technical publications, and other internal and external stakeholders to shape product and procedural innovation. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
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.
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?
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.
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.
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.
Sr. Manager, Clinical Research Engineering Intuitive Surgical IncSr. Manager, Clinical Research EngineeringSunnyvale, CALeveraging deep clinical, scientific, and engineering expertise, this role will partner with engineers, physicians, interaction designers, human factors specialists, training teams, technical publications, and other internal and external stakeholders to shape product and procedural innovation. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
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.
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.
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.