University of California
STAFF001416 Staff Research Associate III (Clinical Research Coordinator)
University of California, San Francisco, California, United States, 94199
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STAFF001416 Staff Research Associate III (Clinical Research Coordinator)STAFF001416 Staff Research Associate III (Clinical Research Coordinator)
Location :4150 Clement St.
San Francisco ,
CA
94121
United StatesJob Posted Date :November 14, 2023Full-time PositionsPopulation :OtherNorthern California Institute for Research and Education (NCIRE) is the leading nonprofit research institute in the United States devoted to advancing Veterans health research. NCIRE is part of one of the world’s most dedicated and successful Veterans care communities, pioneering new treatments and understandings of military medicine and care. Along with our partners at the San Francisco VA Health Care System and the University of California, San Francisco, we are working to discover and develop effective, safe, and practical treatments for military injuries and diseases affecting Veterans.Position Definition :The incumbent will serve as a Staff Research Associate III/Clinical Research Coordinator for various projects and will provide compliance oversight and day-to-day study coordination activities as assigned by the Manager of Compliance and Contracts. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI), Manager of Compliance and Contracts, and the Administrative Nurse II.While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.Essential Functions:Implements the overall direction of clinical research projects as directed by Principal Investigator and/or Manager of Compliance and ContractsAdministratively and clinically manage an average of four to six clinical trialsServe as primary contact for sponsors on administrative and regulatory issuesCoordinate all aspects of the research protocol & manage the daily study operations, managing research budgets, maintain essential research study documentationMaintain all regulatory approvals with Sponsor, UCSF, NCIRE, and SFVA including local, central, or external IRB applications including renewals, amendments, and closeoutPrepare study materials including, but are not limited to, the informed consent and HIPPA document, case report forms (CRFs), enrollment logs, and drug/device accountability logs per SFVA and FDA guidelinesEstablishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materialsCreate and manage systems for tracking, collecting, and monitoring study progress to ensure adherence to protocol timelines and standard operating proceduresCollaborate with VA ancillary departments (e.g. Lab Services, Radiology, CTSI) to ensure processes are set up to meet requirements of study protocolObtain, process and ship required specimens per protocolEnsures adherence to the enrollment goals of the study; maintains study enrollment timelinesWork with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol managementResponsible for providing and documenting Informed ConsentSchedule all assessment study visits, study procedures, and follow up visitsMake necessary arrangements as required to evaluate the subject per study protocolReport any protocol violation/deviation to the Sponsor, IRB & Regulatory Authorities per protocol guidelinesParticipate in subject recruitment efforts and help train supporting staffCoordinate the study Close Out Visit with the sponsor.Manage tasks related to pharmacy and laboratory closeout activities including reconciliation of study drug and temperature logs.Closeout the IRB and SFVA R&DPerform other duties as assignedJob Requirements:Requires a B.S. degree in a scientific discipline, and two to six years of minimum experience with direct research administrationMinimum of 4 years industry experience, with direct clinical trial managementMA/MS degree in scientific or related fields strongly preferredHas a thorough understanding of IRB, protocols policies and practices for conducting clinical investigationsProficient with Microsoft applications (Word, Excel, PowerPoint, and Outlook) other 3rd party EDC/EMR applications. Familiarity with VA CPRS is desiredCertificate (or equivalent) in clinical trials education course(s) is desired.Knowledge of the Principles of Good Clinical Practice (GCP), HIPAA, Bloodborne Pathogens, International Air Transport Association (IATA).Knowledge of IRB, FDA, and other regulatory requirementsAbility to prioritize and organize a high-volume workload and adapt to changing prioritiesExcellent interpersonal, written/oral communication and organizational skills with the ability to present to various audiencesAbility to manage multiple projects, tasks and priorities to achieve desired goals independentlyKnowledge of VA’s health care system regarding clinical research trials is desired.Strong accuracy and attention to detailExcellent organizational skillsAbility to work autonomouslyWorking Conditions/Environment:The work environment for this position is an indoor office environment. The incumbent may sustain posture in a seated position and may utilize a computer terminal for prolonged periods of time.The base salary range for this position is $64,480.00 - $93,059.20 per year. The base salary actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate’s geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations. A successful candidate may also be eligible to earn additional compensation including bonuses.Or apply by visiting us at www.ncire.org and apply for
STAFF001416 Staff Research Associate III (Clinical Research Coordinator) .Northern California Institute for Research and Education (NCIRE) is proud to be an Equal Opportunity Employer.Per San Francisco's Fair Chance Ordinance, Northern California Institute for Research and Education (NCIRE) will consider qualified applicants with criminal histories.
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STAFF001416 Staff Research Associate III (Clinical Research Coordinator)STAFF001416 Staff Research Associate III (Clinical Research Coordinator)
Location :4150 Clement St.
San Francisco ,
CA
94121
United StatesJob Posted Date :November 14, 2023Full-time PositionsPopulation :OtherNorthern California Institute for Research and Education (NCIRE) is the leading nonprofit research institute in the United States devoted to advancing Veterans health research. NCIRE is part of one of the world’s most dedicated and successful Veterans care communities, pioneering new treatments and understandings of military medicine and care. Along with our partners at the San Francisco VA Health Care System and the University of California, San Francisco, we are working to discover and develop effective, safe, and practical treatments for military injuries and diseases affecting Veterans.Position Definition :The incumbent will serve as a Staff Research Associate III/Clinical Research Coordinator for various projects and will provide compliance oversight and day-to-day study coordination activities as assigned by the Manager of Compliance and Contracts. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI), Manager of Compliance and Contracts, and the Administrative Nurse II.While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.Essential Functions:Implements the overall direction of clinical research projects as directed by Principal Investigator and/or Manager of Compliance and ContractsAdministratively and clinically manage an average of four to six clinical trialsServe as primary contact for sponsors on administrative and regulatory issuesCoordinate all aspects of the research protocol & manage the daily study operations, managing research budgets, maintain essential research study documentationMaintain all regulatory approvals with Sponsor, UCSF, NCIRE, and SFVA including local, central, or external IRB applications including renewals, amendments, and closeoutPrepare study materials including, but are not limited to, the informed consent and HIPPA document, case report forms (CRFs), enrollment logs, and drug/device accountability logs per SFVA and FDA guidelinesEstablishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materialsCreate and manage systems for tracking, collecting, and monitoring study progress to ensure adherence to protocol timelines and standard operating proceduresCollaborate with VA ancillary departments (e.g. Lab Services, Radiology, CTSI) to ensure processes are set up to meet requirements of study protocolObtain, process and ship required specimens per protocolEnsures adherence to the enrollment goals of the study; maintains study enrollment timelinesWork with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol managementResponsible for providing and documenting Informed ConsentSchedule all assessment study visits, study procedures, and follow up visitsMake necessary arrangements as required to evaluate the subject per study protocolReport any protocol violation/deviation to the Sponsor, IRB & Regulatory Authorities per protocol guidelinesParticipate in subject recruitment efforts and help train supporting staffCoordinate the study Close Out Visit with the sponsor.Manage tasks related to pharmacy and laboratory closeout activities including reconciliation of study drug and temperature logs.Closeout the IRB and SFVA R&DPerform other duties as assignedJob Requirements:Requires a B.S. degree in a scientific discipline, and two to six years of minimum experience with direct research administrationMinimum of 4 years industry experience, with direct clinical trial managementMA/MS degree in scientific or related fields strongly preferredHas a thorough understanding of IRB, protocols policies and practices for conducting clinical investigationsProficient with Microsoft applications (Word, Excel, PowerPoint, and Outlook) other 3rd party EDC/EMR applications. Familiarity with VA CPRS is desiredCertificate (or equivalent) in clinical trials education course(s) is desired.Knowledge of the Principles of Good Clinical Practice (GCP), HIPAA, Bloodborne Pathogens, International Air Transport Association (IATA).Knowledge of IRB, FDA, and other regulatory requirementsAbility to prioritize and organize a high-volume workload and adapt to changing prioritiesExcellent interpersonal, written/oral communication and organizational skills with the ability to present to various audiencesAbility to manage multiple projects, tasks and priorities to achieve desired goals independentlyKnowledge of VA’s health care system regarding clinical research trials is desired.Strong accuracy and attention to detailExcellent organizational skillsAbility to work autonomouslyWorking Conditions/Environment:The work environment for this position is an indoor office environment. The incumbent may sustain posture in a seated position and may utilize a computer terminal for prolonged periods of time.The base salary range for this position is $64,480.00 - $93,059.20 per year. The base salary actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate’s geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations. A successful candidate may also be eligible to earn additional compensation including bonuses.Or apply by visiting us at www.ncire.org and apply for
STAFF001416 Staff Research Associate III (Clinical Research Coordinator) .Northern California Institute for Research and Education (NCIRE) is proud to be an Equal Opportunity Employer.Per San Francisco's Fair Chance Ordinance, Northern California Institute for Research and Education (NCIRE) will consider qualified applicants with criminal histories.
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