Inside Higher Ed
Sr. Research Program Coordinator II
Inside Higher Ed, Baltimore, Maryland, United States, 21276
Overview
Sr. Research Program Coordinator II – Inside Higher Ed. The Division of Pulmonary and Critical Care Medicine and Director of the Medical Intensive Care Unit (ICU) is seeking a Sr. Research Program Coordinator II who will coordinate and support the research efforts of the JH ICU Clinical Trials Group and participating principal investigators (PI). The JH ICU Clinical Trials Group focuses on clinical trials that investigate therapeutic interventions for critical illness syndromes including sepsis, acute respiratory failure, acute respiratory distress syndrome, liver failure, and renal failure. Interventions may include new therapeutic drugs, devices, or strategies. Most interventions begin in the ICU with follow-up over 2 to 4 weeks and longer-term follow-up at 28 and/or 90 days. Many trials involve biospecimen collection that requires on-site processing prior to storage and shipment to a central lab. Responsibilities
Work closely with the Principal Investigators on studies to ensure timely, accurate submission to the IRB of study applications. Assure study protocols have complete, consistent language throughout. Follow up the status and identify bottlenecks in the approval processes. Obtain all required documents for study submissions to the IRB. Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, and develop and implement systems to decrease delay in the approval process. Analyze data and contribute to writing draft or sections of manuscripts. Develop and maintain study documents such as laboratory manuals. Internally monitor regulatory files and study data to assess compliance, data quality, and accuracy. Complete IRB amendment submissions and ensure documentation of training. Attend study start-up meetings for all studies and present data at meetings as needed. Produce and maintain a regulatory binder prior to study start with all required documents. Work closely with Principal Investigators to ensure all documents are reviewed, approved and correct prior to and during the study. Ensure all documents are collected in a timely manner and regulatory binders are up to date. Assist with study monitoring and auditing requirements. Participate in development, testing and evaluation of manuals, questionnaires, and coding structures for efficient data collection. Conduct training sessions for lower level program coordinators at other locations within a multi-centered clinical trial. Develop standard operating procedures for regulatory submissions as needed. Maintain a continued high level of expertise in institutional databases including REDCap, OpenSpecimen, EPIC, Oncore, and eIRB to ensure accurate data and analysis for all trials within the program. Review and analyze studies for potential difficulties in study processes and procedures; suggest appropriate alternatives. Complete minimum requirements for continuing education units and stay up to date with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies; teach staff about regulatory aspects. Update faculty on regulatory study status. Provide complex project support to the faculty including assistance with grant applications and progress reports, translational research protocols and important correspondence, and project management; handle highly sensitive, privileged, and confidential subject matter. Edit presentations and coordinate communications with internal and external entities. Oversee study budgets and contracts processing through ORA to assure timely execution and completion. When needed, support data collection and entry related to research studies. When needed, assist with participant enrollment in research studies. When needed, transport biospecimens to the lab for processing. Minimum Qualifications
Bachelor’s Degree in a related discipline. Five years related experience. Preferred Qualifications
Master’s Degree. Experience in budget generation, contractual processes, and financial management of clinical trials. Experience in clinical research and regulatory affairs. Experience in protocol and informed consent writing, data analysis, grant writing, and/or manuscript preparation. Knowledge of research methodology and working knowledge of computers. Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: $48,000 - $84,100 ($48,000 Targeted; Commensurate w/ exp.) Employee group: Full Time Schedule: Monday to Friday 8:30 am - 5pm FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Pulmonary Personnel area: School of Medicine The Johns Hopkins University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. EEO is the Law. See https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf Vaccine Information: Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine; the policy may vary by campus. For SOM positions, fully vaccinated with an FDA-approved COVID-19 vaccine and proof of vaccination is required. See https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ for details.
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Sr. Research Program Coordinator II – Inside Higher Ed. The Division of Pulmonary and Critical Care Medicine and Director of the Medical Intensive Care Unit (ICU) is seeking a Sr. Research Program Coordinator II who will coordinate and support the research efforts of the JH ICU Clinical Trials Group and participating principal investigators (PI). The JH ICU Clinical Trials Group focuses on clinical trials that investigate therapeutic interventions for critical illness syndromes including sepsis, acute respiratory failure, acute respiratory distress syndrome, liver failure, and renal failure. Interventions may include new therapeutic drugs, devices, or strategies. Most interventions begin in the ICU with follow-up over 2 to 4 weeks and longer-term follow-up at 28 and/or 90 days. Many trials involve biospecimen collection that requires on-site processing prior to storage and shipment to a central lab. Responsibilities
Work closely with the Principal Investigators on studies to ensure timely, accurate submission to the IRB of study applications. Assure study protocols have complete, consistent language throughout. Follow up the status and identify bottlenecks in the approval processes. Obtain all required documents for study submissions to the IRB. Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, and develop and implement systems to decrease delay in the approval process. Analyze data and contribute to writing draft or sections of manuscripts. Develop and maintain study documents such as laboratory manuals. Internally monitor regulatory files and study data to assess compliance, data quality, and accuracy. Complete IRB amendment submissions and ensure documentation of training. Attend study start-up meetings for all studies and present data at meetings as needed. Produce and maintain a regulatory binder prior to study start with all required documents. Work closely with Principal Investigators to ensure all documents are reviewed, approved and correct prior to and during the study. Ensure all documents are collected in a timely manner and regulatory binders are up to date. Assist with study monitoring and auditing requirements. Participate in development, testing and evaluation of manuals, questionnaires, and coding structures for efficient data collection. Conduct training sessions for lower level program coordinators at other locations within a multi-centered clinical trial. Develop standard operating procedures for regulatory submissions as needed. Maintain a continued high level of expertise in institutional databases including REDCap, OpenSpecimen, EPIC, Oncore, and eIRB to ensure accurate data and analysis for all trials within the program. Review and analyze studies for potential difficulties in study processes and procedures; suggest appropriate alternatives. Complete minimum requirements for continuing education units and stay up to date with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies; teach staff about regulatory aspects. Update faculty on regulatory study status. Provide complex project support to the faculty including assistance with grant applications and progress reports, translational research protocols and important correspondence, and project management; handle highly sensitive, privileged, and confidential subject matter. Edit presentations and coordinate communications with internal and external entities. Oversee study budgets and contracts processing through ORA to assure timely execution and completion. When needed, support data collection and entry related to research studies. When needed, assist with participant enrollment in research studies. When needed, transport biospecimens to the lab for processing. Minimum Qualifications
Bachelor’s Degree in a related discipline. Five years related experience. Preferred Qualifications
Master’s Degree. Experience in budget generation, contractual processes, and financial management of clinical trials. Experience in clinical research and regulatory affairs. Experience in protocol and informed consent writing, data analysis, grant writing, and/or manuscript preparation. Knowledge of research methodology and working knowledge of computers. Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: $48,000 - $84,100 ($48,000 Targeted; Commensurate w/ exp.) Employee group: Full Time Schedule: Monday to Friday 8:30 am - 5pm FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Pulmonary Personnel area: School of Medicine The Johns Hopkins University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. EEO is the Law. See https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf Vaccine Information: Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine; the policy may vary by campus. For SOM positions, fully vaccinated with an FDA-approved COVID-19 vaccine and proof of vaccination is required. See https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ for details.
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