Senior Research Program Coordinator

1 day ago

Baltimore, Maryland, United States Johns Hopkins University Full time
Job Summary

We are seeking a highly skilled and experienced Sr. Research Program Coordinator to join our team in the Division of Pulmonary and Critical Care Medicine. The successful candidate will be responsible for coordinating multi- and single-center, federally- and industry-funded clinical research studies conducted in the ICU and post-ICU settings.

Key Responsibilities
  • Serve as the primary point of contact and liaison between the Principal Investigator, research staff, and budget office & Office of Research Administration at Johns Hopkins University.
  • Coordinate the flow of communication between all entities involved in the research project.
  • Manage the administrative workflow to streamline the execution of contracts/subcontracts and protocol approval processes.
  • Coordinate investigator meetings, data management meetings, meetings with study investigators and study sub-sites.
  • Maintain a detailed working knowledge of assigned protocols; design and compile materials to aid investigators and other research staff in complying with protocol requirements.
  • Oversee and conduct recruitment, screening, and enrolling of eligible patients into assigned protocols.
  • Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit change in research, annual renewals, amendments, and adverse event reports to IRB, DSMB, and sponsor (as applicable).
  • Verify patient eligibility for studies. Identify study participants and be 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.
  • 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.
  • Abstract patient clinical and demographic data from various sources (including paper and electronic medical records multiple electronic platforms) and enter into a CRF, tracking spreadsheet, or database.
  • 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.
  • Perform data management and analyses, including advanced use of spreadsheets and databases for studies.
  • Review protocol amendments to identify changes to treatment orders, study calendar, and risks to subjects. List and clarify concerns & questions about new protocols with PI &/or sponsor.
  • 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.
  • Participate in study initiation meetings. 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.
  • Prepare initial protocol submissions, develop consent forms, and other regulatory documents in compliance with federal, university, departmental, and other regulations.
  • Maintain compliance with HIPAA and IRB regulations and guidelines.
  • Assist in supervising multiple research staff involved in research activities.
  • Administer standardized surveys to research subjects or their proxies via phone, or via in-patient, clinic, or home visits.
  • Prepare weekly reports of work hours and activities for review by the supervisor.
  • Demonstrate and serve as a role model for a positive work environment, including high motivation, positive attitude, and good judgment, tact, and sensitivity in all interpersonal interactions with all research staff, investigators, students, and participants.
  • Able to effectively prioritize and work on multiple tasks with concurrent deadlines and demonstrate excellent time management skills and efficiency.
Requirements
  • Bachelor's Degree in a related discipline.
  • Three years of related experience.
  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
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.
  • All IRB-required courses must be completed, and appropriate exams passed with necessary certification within 2 weeks of start date.

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