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CLINICAL RESEARCH MONITOR(CRA) ORANGE COUNTY
Job Field: Government Jobs
Location: Orange County, CA
Salary: $Not stated
Location: Orange County, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Medtronic is an Equal Opportunity/Affirmative Action EmployerPosition DescriptionThe Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures, study protocols, and procedures and business policies. This position works under general supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues.Position ResponsibilitiesPerform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policiesCommunicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-upPrepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring PlanIdentify site needs, provide solutions to facilitate the clinical trial processAct as a primary point of contact for study sites as requestedAssist in initial and ongoing site personnel training as requiredIdentification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating ProceduresCollaborate with monitoring management and study team personnel towards securing Investigator compliance.Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)Possess a working knowledge of disease state and investigational productPossess understanding of regulatory requirementsAttend internal department and team meeting as requiredAdhere to all applicable Medtronic policies and proceduresIn addition, the Clinical Research Monitor may:Attend Investigator and/or Coordinator meetingsProvide input into final study site selectionBe involved in site management activitiesBe assigned lead monitor responsibilities which include but are not limited to:o Providing input on study protocol, CRFs and other study documentso Authoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheetso Assisting in the creation of corrective and preventive action plans and trending reportso Managing site assignments in collaboration with managero Facilitating communication and information flow between assigned project teams and assigned monitors on projecto Ensuring monitors are trained, current with project requirements and understand study milestoneso Overseeing action item tracking and resolution statuso Performing co-monitoring visits as neededo Ensuring Monitoring Plan requirements are being met and escalates riskso Attending Core/Study team meetingsBasic QualificationsEDUCATION REQUIRED:Bachelor’s DegreeYEARS OF EXPERIENCE:Two (2) years clinical research experienceMust already live in the regionDesired/Preferred QualificationsOne (1) year of Clinical Research monitoringExcellent interpersonal skillsExperience working in a team/matrix environment requiring strong working relationshipsAbility to handle and prioritize multiple therapeutic areas and projects simultaneouslyAbility to work in a fast paced environmentCompetencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfactionDemonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.High attention to detail and accuracyExperience working independently in a regional area with remote or minimal supervisionStrong leadership skillsExcellent problem solving skillsExperience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)Basic unders
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<tr><td valign="top" width="450"><b>Medtronic is an Equal Opportunity/Affirmative Action EmployerPosition DescriptionThe Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures, study protocols, and procedures and business policies. This position works under general supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues.Position ResponsibilitiesPerform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policiesCommunicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-upPrepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring PlanIdentify site needs, provide solutions to facilitate the clinical trial processAct as a primary point of contact for study sites as requestedAssist in initial and ongoing site personnel training as requiredIdentification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating ProceduresCollaborate with monitoring management and study team personnel towards securing Investigator compliance.Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)Possess a working knowledge of disease state and investigational productPossess understanding of regulatory requirementsAttend internal department and team meeting as requiredAdhere to all applicable Medtronic policies and proceduresIn addition, the Clinical Research Monitor may:Attend Investigator and/or Coordinator meetingsProvide input into final study site selectionBe involved in site management activitiesBe assigned lead monitor responsibilities which include but are not limited to:o Providing input on study protocol, CRFs and other study documentso Authoring Monitoring Plans, monitoring section of Data Management Plans, and source document worksheetso Assisting in the creation of corrective and preventive action plans and trending reportso Managing site assignments in collaboration with managero Facilitating communication and information flow between assigned project teams and assigned monitors on projecto Ensuring monitors are trained, current with project requirements and understand study milestoneso Overseeing action item tracking and resolution statuso Performing co-monitoring visits as neededo Ensuring Monitoring Plan requirements are being met and escalates riskso Attending Core/Study team meetingsBasic QualificationsEDUCATION REQUIRED:Bachelor’s DegreeYEARS OF EXPERIENCE:Two (2) years clinical research experienceMust already live in the regionDesired/Preferred QualificationsOne (1) year of Clinical Research monitoringExcellent interpersonal skillsExperience working in a team/matrix environment requiring strong working relationshipsAbility to handle and prioritize multiple therapeutic areas and projects simultaneouslyAbility to work in a fast paced environmentCompetencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfactionDemonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.High attention to detail and accuracyExperience working independently in a regional area with remote or minimal supervisionStrong leadership skillsExcellent problem solving skillsExperience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)Basic unders
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