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.
NewClinical Research Supervisor - Breast Oncology Program UCSF Medical CenterClinical Research Supervisor - Breast Oncology ProgramSan Francisco, CAThe Clinical Research Supervisor's duties may also include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated 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, 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 relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. Trains, supervises, and acts as backstop for 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.
Senior Clinical Research Coordinator UCSF Medical CenterSenior Clinical Research CoordinatorSan Francisco, CAOn the drug-resistant tuberculosis cluster randomized pragmatic trial, the Senior CRC will report to the Principal Investigator and will have central responsibility for ensuring the overall coordination, administration, and monitoring of the trial, which includes close collaboration with academic research partners, public health officials, commercial entities, and non-governmental actors in multiple international settings. Clinical Trials/Research Project Management: Negotiate pre-trial agreements, budget, and supply chains; work with Research Services Analyst and Industry Contracts to execute agreements; set up ancillary departments, train staff as needed, assign tasks, create documentation, and ensure in-country research law compliance.
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 - 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.
Vice President, Clinical Research-Infectious Disease Vir Biotechnology, Inc.Vice President, Clinical Research-Infectious DiseaseSan Francisco, CA$320,000–$410,000 / yearVir Biotechnology seeks a Vice President of Clinical Research to set strategy and lead the development of multiple programs across our infectious disease portfolio, including our Hepatitis Delta program currently in Phase III and BLA‑enabling activities. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN dual-masked T-cell engagers across validated targets in solid tumor indications.
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 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.
Clinical Research Specialist Integrated Resources, IncClinical Research SpecialistSanta Rosa, CaliforniaContractorJob DescriptionDuration: 12 Months+ Contract (possibility of extension)Top 3 qualifications: • Previous clinical research experience • Ability to prioritize and strong critical thinking skills • Attention to detail and strong communication skills Responsibilities: Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. Clinical Research SpecialistIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
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.
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 Clinical Research Coordinator Cardiology UCSF Medical CenterSenior Clinical Research Coordinator CardiologySan Francisco, CAReporting to Clinical Research Supervisor, the incumbent may have central responsibility for ensuring CHR approval and compliance, 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; 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. 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, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
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 Research Coordinator Phlebotomist UCSF Medical CenterClinical Research Coordinator PhlebotomistSan Francisco, CAActive protocols include PREVENT-LC (Early Antiviral Treatment to Prevent Viral Persistence and Inflammation as Drivers of Long COVID), PASC-RECOVER (Post-Acute Sequelae of SARS-CoV-2 Infection - Researching COVID to Enhance Recovery), and the LIINC cohort, and the CRC may be assigned to additional home- or clinic-based studies as the Division's research portfolio evolves. Job Summary: This position sits within the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital (ZSFG), and supports the LIINC (Long-term Impact of Infection with the Novel Coronavirus) and SCOPE (Study on the Consequences of the Protease Inhibitor Era) Research Programs, which conduct clinical and translational research on acute and post-acute infection syndromes related to COVID-19 and HIV.
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).
Clinical Trials Manager (Oncology) Exelixis Inc.Clinical Trials Manager (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).
NewSr 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 Coordinator (Spanish) UCSF Medical CenterClinical Research Coordinator (Spanish)San Francisco, CAKnowledge 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. The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
NewSenior Director, Clinical Research-Medical Director (Oncology) Vir Biotechnology, Inc.Senior Director, Clinical Research-Medical Director (Oncology)San Francisco, CA$235,500–$329,500 / yearThe role requires a physician leader with a strong track record of serving as a Medical Monitor and Clinical Research Physician, partnering closely with Clinical Operations, Clinical Scientists, Pharmacovigilance, Biometrics, and Regulatory teams to ensure safe, high-quality study execution. The Senior Director, Clinical Research (Oncology) will serve as a Medical Director/Medical Monitor within Oncology Clinical Development, providing medical leadership for ongoing clinical trials and ensuring the safety of patients enrolled across Vir Bio's oncology studies.