Allina Health
Research Project Specialist
Allina Health, Minneapolis, Minnesota, United States, 55400
Number of Job Openings Available:
1Date Posted:
August 30, 2024Department:
16000407 Specialty Care Delivery ResearchShift:
Day (United States of America)Shift Length:
8 hour shiftHours Per Week:
40Union Contract:
Non-UnionWeekend Rotation:
NoneJob Summary:
Provides leadership in the clinical research department for clinical trials study activities including patient enrollment and assessments, data management, study material preparation, regulatory document preparation, and project coordination in accordance with research standard operating procedures, federal and state regulations, Institutional Review Board (IRB) requirements, and International Council on Harmonization Good Clinical Practice guidelines.Key Position Details:Master's degree in sciences, epidemiology, public health or related field a plusExperience supporting various research teams preferredClinical or epidemiological research experience requiredJob Description:Principal ResponsibilitiesStudy Management Activities
Screen electronic medical records to identify potential study participants based on protocol inclusion and exclusion criteria.Independently conduct and document the informed consent process with potential research subjects in accordance with research standards of practice (SOP) and Institutional Review Board requirements.Develop, implement, and evaluate the patient's plan of care based upon patient and family assessments.Complete all study-related activities including diagnostics, quality of life assessments, and laboratory procedures. Perform study activities and assessments within the scope of training and certification.Independently manage source documentation and accurately record data in case report forms for each study participant during the study.Communicate with principal investigator, research staff, clinical care teams, and sponsor regarding patient care issues and study progress.Prepare for study monitoring and audit visits and meet with monitor/auditor to resolve any discrepancies.Oversee study close-out and archiving of study data in accordance with research SOPs.
Research Study Start-up
Collect essential regulatory documents and facilitate Institutional Review Board submissions.Review and revise Informed Consent forms to match study protocol, regulatory requirements, and local Institutional Review Board policies.Create study-specific tools and develop study plan of execution.Prepare regulatory documents, study materials, recruitment materials, laboratory kits.Ensure all documents are in compliance with the U.S. Food and Drug Administration regulations.Educate internal and external personnel about studies; provide guidance to clinical staff regarding implementation of study protocol.
Study Feasibility Activities
Evaluate new study protocols to determine feasibility at the site, target enrollment goals related to available study population, and potential budget items to perform the study.Anticipate and order special equipment and laboratory supplies for new studies.Provide Radiology and Imaging Capabilities Assessment Forms and phantom images required during study feasibility.
Data and Invoice Activities
Perform trial related invoicing and reimbursements with system and study sponsors.Maintain study database and perform data extraction from electronic medical records and/or patient charts.Conduct ongoing data analysis to generate interim study reports.
Job RequirementsAssociate's or Vocational degree in medical field required orBachelor's degree in biological sciences or related field preferred or2 to 5 years experience in research requiredBLS Tier 1 - Basic Life Support - Multisource required upon hire andInternational Air Transport Association Certification upon hire required andCertified Clinical Research Coordinator preferred upon hire within 1 Year required orCertified Clinical Research Professional preferred upon hire within 1 Year requiredPhysical DemandsSedentary:Lifting weight Up to 10 lbs. occasionally, negligible weight frequently
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1Date Posted:
August 30, 2024Department:
16000407 Specialty Care Delivery ResearchShift:
Day (United States of America)Shift Length:
8 hour shiftHours Per Week:
40Union Contract:
Non-UnionWeekend Rotation:
NoneJob Summary:
Provides leadership in the clinical research department for clinical trials study activities including patient enrollment and assessments, data management, study material preparation, regulatory document preparation, and project coordination in accordance with research standard operating procedures, federal and state regulations, Institutional Review Board (IRB) requirements, and International Council on Harmonization Good Clinical Practice guidelines.Key Position Details:Master's degree in sciences, epidemiology, public health or related field a plusExperience supporting various research teams preferredClinical or epidemiological research experience requiredJob Description:Principal ResponsibilitiesStudy Management Activities
Screen electronic medical records to identify potential study participants based on protocol inclusion and exclusion criteria.Independently conduct and document the informed consent process with potential research subjects in accordance with research standards of practice (SOP) and Institutional Review Board requirements.Develop, implement, and evaluate the patient's plan of care based upon patient and family assessments.Complete all study-related activities including diagnostics, quality of life assessments, and laboratory procedures. Perform study activities and assessments within the scope of training and certification.Independently manage source documentation and accurately record data in case report forms for each study participant during the study.Communicate with principal investigator, research staff, clinical care teams, and sponsor regarding patient care issues and study progress.Prepare for study monitoring and audit visits and meet with monitor/auditor to resolve any discrepancies.Oversee study close-out and archiving of study data in accordance with research SOPs.
Research Study Start-up
Collect essential regulatory documents and facilitate Institutional Review Board submissions.Review and revise Informed Consent forms to match study protocol, regulatory requirements, and local Institutional Review Board policies.Create study-specific tools and develop study plan of execution.Prepare regulatory documents, study materials, recruitment materials, laboratory kits.Ensure all documents are in compliance with the U.S. Food and Drug Administration regulations.Educate internal and external personnel about studies; provide guidance to clinical staff regarding implementation of study protocol.
Study Feasibility Activities
Evaluate new study protocols to determine feasibility at the site, target enrollment goals related to available study population, and potential budget items to perform the study.Anticipate and order special equipment and laboratory supplies for new studies.Provide Radiology and Imaging Capabilities Assessment Forms and phantom images required during study feasibility.
Data and Invoice Activities
Perform trial related invoicing and reimbursements with system and study sponsors.Maintain study database and perform data extraction from electronic medical records and/or patient charts.Conduct ongoing data analysis to generate interim study reports.
Job RequirementsAssociate's or Vocational degree in medical field required orBachelor's degree in biological sciences or related field preferred or2 to 5 years experience in research requiredBLS Tier 1 - Basic Life Support - Multisource required upon hire andInternational Air Transport Association Certification upon hire required andCertified Clinical Research Coordinator preferred upon hire within 1 Year required orCertified Clinical Research Professional preferred upon hire within 1 Year requiredPhysical DemandsSedentary:Lifting weight Up to 10 lbs. occasionally, negligible weight frequently
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