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 Project Manager Clinical Research AbbottSenior Project Manager Clinical ResearchAlameda, California$100,000–$200,000 / yearGeneral Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
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 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.
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.
Clinical data Manager Integrated Resources, IncClinical data ManagerFoster City, CaliforniaContractorWorks collaboratively with biomarker clinical operations team members, biomarker scientists, biomarker statistical programming group, biomarker biostatistics group, biomarker clinical programming group, biobanking and sample management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking, and reporting. The ideal candidate should possess a BS degree or higher in a biomedical science or equivalent and minimum 3 years of relevant clinical data management experience and preferably along with biomarker or laboratory background and experience in a CRO or bio/pharmaceutical setting.
Clinical data manager Integrated Resources, IncClinical data managerFoster City, CaliforniaContractorWorks collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Bio banking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting. QualificationsLead clinical data manager with 3 -5 years of Sponsor or CRO or Academic experienceUnderstanding of clinical data management processesProject management experience of clinical trialsCommunication with cross-functional study team members
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 Trials Manager - II Integrated Resources, IncClinical Trials Manager - IIFoster City, CaliforniaContractorIn partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Clinical Trials Manager - IIMust meet all requirements for Principal Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
Clinical Trials Manager II Integrated Resources, IncClinical Trials Manager IIFoster City, CaliforniaContractorIT Life Sciences Allied Healthcare CRODIRECT # - (650)-399-0891Gold Seal JCAHO Certified for Health Care Staffing"INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row) In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
Clinical Trials Manager Integrated Resources, IncClinical Trials ManagerFoster City, CaliforniaContractorClinical Trials ManagerIn partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
NewClinical Research Assistant Mass General BrighamClinical Research AssistantBelmont, California$21.53–$29.08 / hourThe Neurobiology of Fear lab at McLean and Center for Suicide Research and Prevention at MGB/Harvard is seeking applications for 1 full-time Clinical Research Assistant (CRA) to coordinate and administer an NIMH-funded project aimed at using mobile devices to understand, predict, and intervene to prevent suicidal behavior among adults recently hospitalized on a psychiatric inpatient unit. The Ressler Lab in McLean’s Depression & Anxiety Division seeks to advance what is known about the brain, behavior, and symptom mechanisms underlying adult mental health conditions, including suicide, non-suicidal self-injury, depression, PTSD, anxiety, and bipolar disorder.
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) •.
NewOn-site Clinical Research Associate Protagonist Therapeutics IncOn-site Clinical Research AssociateNewark, CA$125,000–$135,000 / yearThe Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.
Clinical 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.
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.
Senior Scientist, Clinical Research Merck & Co IncSenior Scientist, Clinical ResearchSouth San Francisco, CA$117,000–$184,200 / yearCo-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
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.