The Johns Hopkins University
Sr. Research Program Coordinator
The Johns Hopkins University, Baltimore, Maryland, United States, 21276
Overview
We are seeking a
Sr. Research Program Coordinator
who will coordinate multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU settings for the Division of Pulmonary and Critical Care Medicine. The coordinator will perform, train and/or supervise duties, including consenting, collecting and entering clinical data, and carrying out related research duties for new and ongoing studies based in the ICU. The coordinator will prepare project progress reports, conduct literature searches, assist with manuscript preparation, and provide support for grant applications. Specific Duties & Responsibilities
Maintain detailed working knowledge of assigned protocols; design and compile materials which aid investigators and other research staff in complying with protocol requirements. Prepare initial protocol submissions, develop consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations. Serve as the primary point of contact and liaison between PI, research staff, budget office, Office of Research Administration, and other administrative/regulatory areas. Coordinate flow of communication between all entities involved in research projects. Manage administrative workflow to streamline the execution of contracts/subcontracts and protocol approval processes. Participate in study initiation meetings. Maintain regulatory binders/spreadsheets for assigned protocols. Oversee and conduct recruitment, screening, and enrolling of eligible patients into assigned protocols. Verifies patient eligibility for studies. Identifies study participants and is involved in their recruitment process on various clinical trials. Obtain informed consent from participants or their legally authorized representatives, explain assigned protocols in detail and conduct informed consent procedures according to required process and protocol eligibility criteria. Abstract patient clinical and demographic data from a variety of sources (including paper and electronic medical records on multiple electronic platforms) and enter into a CRF, tracking spreadsheet or database. Administer standardized surveys to research subjects or their proxies via phone, or via in-patient, clinic or home visits. Communicate and collaborate with the PI, treating physician, study coordinators and other members of the study team on an ongoing basis regarding the implementation of the protocol and status of subjects. Coordinate investigator meetings, data management meetings, meetings with study investigators and study sub-sites. Perform data management and analyses, including advanced use of spreadsheets and databases for studies. Ensure accuracy and timeliness of data collection entry, management and analyses. Monitor compliance with data quality assurance and quality control goals of clinical studies and follow all written and unwritten study practices, procedures and protocols. Prepare and submit changes in research, annual renewals, amendments, and adverse event reports to IRB, DSMB, and sponsor (as applicable). Assist in the preparation of IRB, DSMB, and sponsor reports. Provide timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits. Coordinate serious adverse event reporting with the investigators to ensure prompt reporting to the IRB, DSMB, and study sponsor. Review protocol amendments to identify changes to treatment orders, study calendar and risks to subjects; list and clarify concerns and questions about new protocols with PI and/or sponsor. Prepare for and participate in monitoring and audits of studies. Correct errors in database when necessary. Write responses to audit reports with input from the Principal Investigator. Maintain compliance with HIPAA and IRB regulations and guidelines. Assist in supervising multiple research staff involved in research activities. Prepare weekly reports of activities for supervisor. Additional Knowledge, Skills, and Abilities
Excellent oral and written communication skills. Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills. Excellent organizational and time-management skills. Ability to use personal computer, proficiency in Microsoft Word and Excel and database software (e.g. REDCap, ACCESS). Able to effectively prioritize and work on multiple tasks with concurrent deadlines and demonstrate excellent time management skills and efficiency. Minimum Qualifications
Bachelor\'s Degree in a related discipline. Three years related experience. Additional education may substitute for required experience to the extent permitted by the JHU equivalency formula. All IRB-required courses must be completed and appropriate exams passed with necessary certification within two weeks of the start date. Preferred Qualifications
Master’s Degree. Experience with multi-site clinical trials. Experience with budgeting, invoicing, NIH and/or Department of Defense research progress reports, IRB management. Petty cash disbursement and reconciliation experience. Experience using REDCap. Classified Title: Sr. Research Project Coordinator Job Posting Title (Working Title): Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $71,300 Annually ($55,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: Monday to Friday 8:30am to 5pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Pulmonary Personnel area: School of Medicine Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion. 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. Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/. Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/. The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella, Rubeola, Mumps, Varicella, Hepatitis B and documentation of having received the Tdap vaccination. This may include documentation of having two MMR vaccines; two Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office. School of Medicine - East Baltimore Campus
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We are seeking a
Sr. Research Program Coordinator
who will coordinate multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU settings for the Division of Pulmonary and Critical Care Medicine. The coordinator will perform, train and/or supervise duties, including consenting, collecting and entering clinical data, and carrying out related research duties for new and ongoing studies based in the ICU. The coordinator will prepare project progress reports, conduct literature searches, assist with manuscript preparation, and provide support for grant applications. Specific Duties & Responsibilities
Maintain detailed working knowledge of assigned protocols; design and compile materials which aid investigators and other research staff in complying with protocol requirements. Prepare initial protocol submissions, develop consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations. Serve as the primary point of contact and liaison between PI, research staff, budget office, Office of Research Administration, and other administrative/regulatory areas. Coordinate flow of communication between all entities involved in research projects. Manage administrative workflow to streamline the execution of contracts/subcontracts and protocol approval processes. Participate in study initiation meetings. Maintain regulatory binders/spreadsheets for assigned protocols. Oversee and conduct recruitment, screening, and enrolling of eligible patients into assigned protocols. Verifies patient eligibility for studies. Identifies study participants and is involved in their recruitment process on various clinical trials. Obtain informed consent from participants or their legally authorized representatives, explain assigned protocols in detail and conduct informed consent procedures according to required process and protocol eligibility criteria. Abstract patient clinical and demographic data from a variety of sources (including paper and electronic medical records on multiple electronic platforms) and enter into a CRF, tracking spreadsheet or database. Administer standardized surveys to research subjects or their proxies via phone, or via in-patient, clinic or home visits. Communicate and collaborate with the PI, treating physician, study coordinators and other members of the study team on an ongoing basis regarding the implementation of the protocol and status of subjects. Coordinate investigator meetings, data management meetings, meetings with study investigators and study sub-sites. Perform data management and analyses, including advanced use of spreadsheets and databases for studies. Ensure accuracy and timeliness of data collection entry, management and analyses. Monitor compliance with data quality assurance and quality control goals of clinical studies and follow all written and unwritten study practices, procedures and protocols. Prepare and submit changes in research, annual renewals, amendments, and adverse event reports to IRB, DSMB, and sponsor (as applicable). Assist in the preparation of IRB, DSMB, and sponsor reports. Provide timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits. Coordinate serious adverse event reporting with the investigators to ensure prompt reporting to the IRB, DSMB, and study sponsor. Review protocol amendments to identify changes to treatment orders, study calendar and risks to subjects; list and clarify concerns and questions about new protocols with PI and/or sponsor. Prepare for and participate in monitoring and audits of studies. Correct errors in database when necessary. Write responses to audit reports with input from the Principal Investigator. Maintain compliance with HIPAA and IRB regulations and guidelines. Assist in supervising multiple research staff involved in research activities. Prepare weekly reports of activities for supervisor. Additional Knowledge, Skills, and Abilities
Excellent oral and written communication skills. Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills. Excellent organizational and time-management skills. Ability to use personal computer, proficiency in Microsoft Word and Excel and database software (e.g. REDCap, ACCESS). Able to effectively prioritize and work on multiple tasks with concurrent deadlines and demonstrate excellent time management skills and efficiency. Minimum Qualifications
Bachelor\'s Degree in a related discipline. Three years related experience. Additional education may substitute for required experience to the extent permitted by the JHU equivalency formula. All IRB-required courses must be completed and appropriate exams passed with necessary certification within two weeks of the start date. Preferred Qualifications
Master’s Degree. Experience with multi-site clinical trials. Experience with budgeting, invoicing, NIH and/or Department of Defense research progress reports, IRB management. Petty cash disbursement and reconciliation experience. Experience using REDCap. Classified Title: Sr. Research Project Coordinator Job Posting Title (Working Title): Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $71,300 Annually ($55,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: Monday to Friday 8:30am to 5pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Pulmonary Personnel area: School of Medicine Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion. 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. Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/. Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/. The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella, Rubeola, Mumps, Varicella, Hepatitis B and documentation of having received the Tdap vaccination. This may include documentation of having two MMR vaccines; two Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office. School of Medicine - East Baltimore Campus
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