Inside Higher Ed
Sr. Research Program Coordinator II
Inside Higher Ed, Baltimore, Maryland, United States, 21276
Overview
Join to apply for the Sr. Research Program Coordinator II role at 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 investigating 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 for 2 to 4 weeks and longer-term follow-up at 28 and/or 90 days. Biospecimen collection may be required with on-site processing before 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; follow up on 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 recurrent problems, and develop and implement systems to decrease delays. Analyze data and contribute to writing drafts 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 startup meetings for all studies and present data as needed. Produce and maintain a regulatory binder prior to study start with all required documents. Work with Principal Investigators to ensure all documents are reviewed, approved, and current. Ensure timely collection of documents and up-to-date regulatory binders. 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 multi-centered trials. Develop standard operating procedures for regulatory submissions as needed. Maintain expertise in institutional databases (e.g., REDCap, OpenSpecimen, EPIC, Oncore, eIRB) to ensure accurate data and analysis for all trials. Review and analyze studies to identify process difficulties and suggest alternatives. Meet continuing education requirements and stay up to date with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies; educate staff on regulatory aspects. Update faculty on regulatory study status. Provide complex project support to faculty, including assistance with grant applications and progress reports, translational research protocols, important correspondence, and project management. Edit presentations and coordinate communications with internal and external entities. Oversee study budgets and contracts processing through ORA to ensure timely execution and completion. As time permits, assist with data collection/entry and participant enrollment in studies. When needed, transport biospecimens to the lab for processing. Qualifications
Minimum: Bachelors Degree in a related discipline; five years of related experience. Preferred: Masters 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 computer proficiency. Additional Details
Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: $48,000 - $84,100 (Targeted $48,000; commensurate with experience) Employee group: Full Time Schedule: Monday to Friday, 8:30 am 5:00 pm FLSA Status: Exempt Location: School of Medicine Campus Department: SOM DOM Pulmonary 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. See EEO information and Disability accommodations details in the full job posting. #J-18808-Ljbffr
Join to apply for the Sr. Research Program Coordinator II role at 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 investigating 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 for 2 to 4 weeks and longer-term follow-up at 28 and/or 90 days. Biospecimen collection may be required with on-site processing before 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; follow up on 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 recurrent problems, and develop and implement systems to decrease delays. Analyze data and contribute to writing drafts 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 startup meetings for all studies and present data as needed. Produce and maintain a regulatory binder prior to study start with all required documents. Work with Principal Investigators to ensure all documents are reviewed, approved, and current. Ensure timely collection of documents and up-to-date regulatory binders. 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 multi-centered trials. Develop standard operating procedures for regulatory submissions as needed. Maintain expertise in institutional databases (e.g., REDCap, OpenSpecimen, EPIC, Oncore, eIRB) to ensure accurate data and analysis for all trials. Review and analyze studies to identify process difficulties and suggest alternatives. Meet continuing education requirements and stay up to date with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies; educate staff on regulatory aspects. Update faculty on regulatory study status. Provide complex project support to faculty, including assistance with grant applications and progress reports, translational research protocols, important correspondence, and project management. Edit presentations and coordinate communications with internal and external entities. Oversee study budgets and contracts processing through ORA to ensure timely execution and completion. As time permits, assist with data collection/entry and participant enrollment in studies. When needed, transport biospecimens to the lab for processing. Qualifications
Minimum: Bachelors Degree in a related discipline; five years of related experience. Preferred: Masters 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 computer proficiency. Additional Details
Classified Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: $48,000 - $84,100 (Targeted $48,000; commensurate with experience) Employee group: Full Time Schedule: Monday to Friday, 8:30 am 5:00 pm FLSA Status: Exempt Location: School of Medicine Campus Department: SOM DOM Pulmonary 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. See EEO information and Disability accommodations details in the full job posting. #J-18808-Ljbffr