Research Program Coordinator
Job Req ID: 113789
Research Program Coordinator
Under the direct supervision of the Research Program Manager, the Department of Medicine is seeking a Research Program Coordinator who will be responsible for monitoring and collecting research data for sickle cell disease in the Division of Hematology. The Research Program Coordinator (RPC) is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials and may assist with orientation of less senior research staff in protocol and clinical research information. The coordinator will help with consenting, collecting research samples and delivering them to the lab, and helping to prepare monthly data reports to the PI and collaborating investigators. The RPC may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an intermediate level position in managing research trials and registry databases within the research program.
Specific Duties & Responsibilities
Oversee and conduct recruitment, screening and enrolling of eligible patients into laboratory protocols.
Explain the protocol in detail and conduct informed consent procedures with potential research participants.
Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction.
Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data.
Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed. Assist less experienced staff in design and creation of such forms.
Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication.
Design and compile materials which aid physicians/other staff in complying with protocol requirements.
Meet regularly with Principal Investigator to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management. Participate in data analysis as needed.
Meet with department financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Participate in the development of invoicing schedules.
Prepare for and participate in monitoring and audits of studies. Write responses to audit reports with input from the Principal Investigator.
Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
Prepare and submit invoices to sponsors in a timely manner.
Work with Divisional finance staff to ensure that all invoice amounts are collected and reconciled periodically.
Perform all other duties as assigned.
Minimum Qualifications
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Excellent organizational skills required.
Excellent attention to detail skills required.
Proven ability to manage multiple and competing priorities.
Excellent time management skills.
Excellent oral and written communication skills.
Demonstrated ability to work well with other professionals with minimal supervision.
Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($50,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: m-f 8:30 - 5
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Hematology
Personnel area: School of Medicine
Total Rewards
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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.
EEO is the Law:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf
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/.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. 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. 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 (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) 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.
Hybrid: On-site 3-4 days a weekEstimated Salary: $20 to $28 per hour based on qualifications.
Research Program Coordinator
Under the direct supervision of the Research Program Manager, the Department of Medicine is seeking a Research Program Coordinator who will be responsible for monitoring and collecting research data for sickle cell disease in the Division of Hematology. The Research Program Coordinator (RPC) is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials and may assist with orientation of less senior research staff in protocol and clinical research information. The coordinator will help with consenting, collecting research samples and delivering them to the lab, and helping to prepare monthly data reports to the PI and collaborating investigators. The RPC may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an intermediate level position in managing research trials and registry databases within the research program.
Specific Duties & Responsibilities
Oversee and conduct recruitment, screening and enrolling of eligible patients into laboratory protocols.
Explain the protocol in detail and conduct informed consent procedures with potential research participants.
Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction.
Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data.
Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed. Assist less experienced staff in design and creation of such forms.
Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication.
Design and compile materials which aid physicians/other staff in complying with protocol requirements.
Meet regularly with Principal Investigator to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management. Participate in data analysis as needed.
Meet with department financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Participate in the development of invoicing schedules.
Prepare for and participate in monitoring and audits of studies. Write responses to audit reports with input from the Principal Investigator.
Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
Prepare and submit invoices to sponsors in a timely manner.
Work with Divisional finance staff to ensure that all invoice amounts are collected and reconciled periodically.
Perform all other duties as assigned.
Minimum Qualifications
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Excellent organizational skills required.
Excellent attention to detail skills required.
Proven ability to manage multiple and competing priorities.
Excellent time management skills.
Excellent oral and written communication skills.
Demonstrated ability to work well with other professionals with minimal supervision.
Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($50,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: m-f 8:30 - 5
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Hematology
Personnel area: School of Medicine
Total Rewards
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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.
EEO is the Law:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf
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/.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. 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. 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 (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) 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.
Hybrid: On-site 3-4 days a weekEstimated Salary: $20 to $28 per hour based on qualifications.
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