Sr. Research Program Coordinator II

Sr. Research Program Coordinator II – Johns Hopkins University, School of Medicine, Pulmonary & Critical Care Medicine Division

This position coordinates and supports research activities of the Johns Hopkins ICU Clinical Trials Group and participating principal investigators.

• Work closely with Principal Investigators to ensure timely, accurate submission of study protocols to the Institutional Review Board (IRB) and track approval status.
• Obtain and organize all required documents for IRB submissions, including amendments. Verify training documentation and prepare regulatory binders.
• Monitor regulatory files and study data to assess compliance, data quality and accuracy, and implement systems to reduce approval delays.
• Analyze trial data and contribute to manuscript drafting and presentation preparation.
• Develop and maintain study documents such as laboratory manuals, questionnaires and coding structures, and standard operating procedures for regulatory submissions.
• Conduct training for program coordinators at.kother centers,mastand provide project support for academic grant applications, progress reports, and regulatory correspondence.
• Assist with study monitoring/auditing requirements, participant enrollment and biospecimen transport to arom the central laboratory.
• Manage study budgets and contract processing via ORA, ensuring timely execution.

• Bachelor's degree in a related discipline.
• Five (5) years of related experience in clinical research or regulatory affairs.

• Master's degree.
• Experience in budget generation, contract management and financial oversight of clinical trials.
• Experience in protocol writing, informed consent drafting, data analysis, grant writing or manuscript preparation.
• Knowledge of research methodology and proficiency with research databases (REDCap, Open Specimen, EPIC, OnCore, eIRB).

$48,000 – $84,100 annually (target $48,000; commensurate with experience). Fully taxable.

School of Medicine Campus, Baltimore, MD.

Full-time, Monday–Friday 8:30 am–5 pm. Exempt under FLSA.

Johns Hopkins University is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. EEO is the Law. https://(Use the "Apply for this Job" box below)./default多野有限/n