Sutter West Bay Medical Group
Clinical Research Coordinator – Interventional Endoscopy
Sutter West Bay Medical Group, San Francisco, California, United States, 94199
Clinical Research Coordinator – Interventional EndoscopyThe distinguished Paul May and Frank Stein Interventional Endoscopy Center is the premier referral center in Northern California and the greater region for patients requiring complex endoscopic therapy. Led by Dr. Kenneth Binmoeller, who founded the Interventional Endoscopy Services (IES) program at California Pacific Medical Center in 2001, the Center provides the most advanced minimally invasive approach that endoscopy affords, providing an enormous benefit to patients as well as substantial healthcare cost savings. The center is dedicated to providing exceptional patient care, developing and performing innovative endoscopic treatments, and conducting cutting-edge medical research. We are currently seeking a highly qualified CRC to join this center, where you will play a vital role in coordinating and managing research activities within our interventional endoscopy program, contributing to the development of new interventions and improving patient outcomes.The
Clinical Research Coordinator (CRC)
will join the California Pacific Medical Center Division of Interventional Endoscopy to manage clinical research studies related to innovative advanced endoscopic interventions and their associated outcomes. This individual will oversee and implement multiple clinical studies under research protocols developed in conjunction with Principal Investigators (PIs) and the CPMC Research Institute. The ideal candidate will have a strong background in clinical research, with specific expertise in procedural outcomes research.Job Responsibilities:Study Coordination and Data Collection
Identify, screen, and enroll potential subjectsDevelop and implement strategies for subject recruitmentObtain informed consent for research studiesWork with PI and other investigators to ensure study protocol complianceData extraction from medical records and patient interviewsProspectively monitor procedure outcomes and complicationsMonitor outcomes of follow-up procedures
Data Management and Result Reporting
Timely data collection and database entryMaintain complete and accurate recordsDatabase creation and modificationQuery and analysis of existing data setsAttend regular Division of Interventional Endoscopy meetings to provide work in progress updatesAssist in staff training regarding data collection and entryAssist in procedure video cataloguing and editing for research reporting
Research sub-investigator training
Oversight of clinical resident and fellow research projects
Quality Control
Maintain data accuracy and consistent, replicable data collection processesDevelop and maintain quality audit process
Study Conduction
Employ various data collection methods and processesAutomate prospective data collection where possibleMaintain process for study subject tracking
Specimen Collection and Biobank
Work with relevant Sutter, CPMC, and inter-institutional biobanks for specimen storage and analysis when appropriate for research studyMaintain process for specimen trackingWork with relevant clinical division to attain radiologic and pathologic specimen interpretation information
Protocol Generation and Compliance
Protocol Creation and Submission to Institutional Review BoardWork with the CPMC Interventional Endoscopy Data Analyst to create data collection methods and electronic entry formsGeneration of manuscripts for submission in collaboration with PI and sub-InvestigatorsRenew and modify existing research protocolsMonitor expiration dates of existing research protocolsMonitor study progress, enrollment numbersEnsure adherence to protocol requirements and deadlines and address any deviations
Regulatory Compliance
Ensure studies are conceived and applied in compliance with IRB, institutional, state, and federal regulationsStore and maintain regulatory documentsPrepare necessary documents for internal and external regulatory auditsEnsure adherence to protocol requirements and deadlinesEnsure compliance with ethical and legal patient privacy requirements throughout study development, implementation, and post-study reporting
Qualifications:Required:Excellent organizational skillsIndependently motivated and self-directed to balance multiple projects and complete them in timely fashionStrong written and verbal communication skills for cordial, effective interaction with study subjects and institutional staffInterest in clinical or research-based medical career2-year commitmentBA or BS degree in life sciences or pre-health field (MD and/or PhD preferred)1 year of clinical research experienceExperience with Epic EMRExperience with database managementStrong knowledge of research methodologies, data collection techniques, and regulatory requirementsPreferred:Experience with database managementExperience in statistical analysis in outcomes researchMaster’s degree in life science or health-related fieldExperience working in a healthcare or academic research setting, preferably with exposure to endoscopic procedures and gastrointestinal disordersPrior experience with clinical trial management, protocol development, and IRB submission is highly desirable.
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Clinical Research Coordinator (CRC)
will join the California Pacific Medical Center Division of Interventional Endoscopy to manage clinical research studies related to innovative advanced endoscopic interventions and their associated outcomes. This individual will oversee and implement multiple clinical studies under research protocols developed in conjunction with Principal Investigators (PIs) and the CPMC Research Institute. The ideal candidate will have a strong background in clinical research, with specific expertise in procedural outcomes research.Job Responsibilities:Study Coordination and Data Collection
Identify, screen, and enroll potential subjectsDevelop and implement strategies for subject recruitmentObtain informed consent for research studiesWork with PI and other investigators to ensure study protocol complianceData extraction from medical records and patient interviewsProspectively monitor procedure outcomes and complicationsMonitor outcomes of follow-up procedures
Data Management and Result Reporting
Timely data collection and database entryMaintain complete and accurate recordsDatabase creation and modificationQuery and analysis of existing data setsAttend regular Division of Interventional Endoscopy meetings to provide work in progress updatesAssist in staff training regarding data collection and entryAssist in procedure video cataloguing and editing for research reporting
Research sub-investigator training
Oversight of clinical resident and fellow research projects
Quality Control
Maintain data accuracy and consistent, replicable data collection processesDevelop and maintain quality audit process
Study Conduction
Employ various data collection methods and processesAutomate prospective data collection where possibleMaintain process for study subject tracking
Specimen Collection and Biobank
Work with relevant Sutter, CPMC, and inter-institutional biobanks for specimen storage and analysis when appropriate for research studyMaintain process for specimen trackingWork with relevant clinical division to attain radiologic and pathologic specimen interpretation information
Protocol Generation and Compliance
Protocol Creation and Submission to Institutional Review BoardWork with the CPMC Interventional Endoscopy Data Analyst to create data collection methods and electronic entry formsGeneration of manuscripts for submission in collaboration with PI and sub-InvestigatorsRenew and modify existing research protocolsMonitor expiration dates of existing research protocolsMonitor study progress, enrollment numbersEnsure adherence to protocol requirements and deadlines and address any deviations
Regulatory Compliance
Ensure studies are conceived and applied in compliance with IRB, institutional, state, and federal regulationsStore and maintain regulatory documentsPrepare necessary documents for internal and external regulatory auditsEnsure adherence to protocol requirements and deadlinesEnsure compliance with ethical and legal patient privacy requirements throughout study development, implementation, and post-study reporting
Qualifications:Required:Excellent organizational skillsIndependently motivated and self-directed to balance multiple projects and complete them in timely fashionStrong written and verbal communication skills for cordial, effective interaction with study subjects and institutional staffInterest in clinical or research-based medical career2-year commitmentBA or BS degree in life sciences or pre-health field (MD and/or PhD preferred)1 year of clinical research experienceExperience with Epic EMRExperience with database managementStrong knowledge of research methodologies, data collection techniques, and regulatory requirementsPreferred:Experience with database managementExperience in statistical analysis in outcomes researchMaster’s degree in life science or health-related fieldExperience working in a healthcare or academic research setting, preferably with exposure to endoscopic procedures and gastrointestinal disordersPrior experience with clinical trial management, protocol development, and IRB submission is highly desirable.
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