Sr. Research Program Coordinator II

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 have duties and responsibilities related to coordinating and supporting the research efforts of the JH ICU Clinical Trials Group and participating principal investigators (PI).

The JH ICU Clinical Trials Group is focused on clinical trials that investigate therapeutic interventions for different 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 for these trials begin in the ICU, with close follow-up for 2 to 4 weeks and longer term follow up at 28 and / or 90 days. Each trial is a little different depending on the intervention being studied. Most will include collection of biospecimens that will need on-site processing before being stored and then shipped to a central lab at a later date.

Specific Duties & Responsibilities

• Work closely with the Principal Investigators on studies to ensure timely, accurate submission to the IRB of studies 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, 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 starting with all required documents.
• Work closely with Principal Investigators to ensure all documents are reviewed, approved and correct prior and during the study.
• Ensure all documents are being collected in a timely manner and all regulatory binders are up to date.
• Assist with study monitoring / auditing requirements.
• Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
• Conduct training sessions for lower level program coordinators working at other locations within 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, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
• Review and analyze studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.
• Complete minimum requirements for continuing education units. Maintain up to date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Teaches staff about regulatory aspects.
• Updates faculty on regulatory study status.
• Provide complex project support to the faculty including assistance with grant application and progress report, translational research protocols and important correspondence, and project management. This person will deal regularly with highly sensitive, privileged and confidential subject matter.
• Edit presentations.
• Coordinate and manage communications work with internal and external entities.
• Oversight of study budgets and contracts processing through ORA to assure execution and completion in a timely manner.
• If needed and as time permits, support data collection and entry related to research studies.
• If needed and as time permits, help with participant enrollment in research studies.
• If needed and as time permits, transport biospecimens to lab for processing.

Minimum Qualifications

Preferred Qualifications

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

Total Rewards

The referenced base salary range represents the low and high end of Johns Hopkins University's salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education / training and other qualifications. 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 / .

Education and Experience Equivalency

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 Completing Studies

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.

Background Checks

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.

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.

EEOis 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 / .

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 (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.