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Research Program Coordinator

2 weeks ago

Baltimore, MD, United States Johns Hopkins University Full time

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Research Program Coordinator who will administratively coordinate clinical protocol implementation, typically for a single study. Will ensure the efficient logistical implementation of the study activities and provide administrative support for research-related regulatory issues.

Specific Duties & Responsibilities

  • Coordinate all activities of a clinical research study to ensure adherence to protocol and validity of findings.

  • Participate in clinical study start-up meeting.

  • Assist research nurses, study coordinators, principal investigators, and other study personnel in executing protocol related activities.

  • Explain the study background and rationale for the research to potential and current participants

  • Contribute to development of recruitment strategy for participants for assigned study.

  • Implement a variety of techniques for recruitment as appropriate, e.g., print and web-based advertisements, contact referring physicians, participate in community events, etc.

  • Independently conduct consenting process or ensure consent is obtained on appropriate participants.

  • Schedule participants for required activities and provide any special instructions prior to upcoming tests/exams.

  • Serve as liaison to study participants.

  • Assist with set up of data collection system and enter and organize data.

  • Assist in coordinating study meetings.

  • Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.

  • Assist with preparation of submissions to the Institutional Review Board (IRB)

  • Liaison with IRB on administrative matters and facilitate communications with the PI.

  • Conduct literature searches to provide background information.

  • Obtain and maintain excellent operating knowledge of assigned clinical protocol, clinical equipment, and clinical computer systems.

  • Oversee budget expenditures for study operations.

Minimum Qualifications

  • Bachelor's Degree in a related field.

  • Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

  • Related undergraduate or work experience in human subjects research.

  • Ensure that coordinating center standards for performance of clinical trials at multiple sites are adhered to.

  • Ensure system for generation, tracking, and resolution of data queries is adhered to.

  • Coordinate and conduct audits, monitoring visits and inspections at all participating sites.

  • Prepare reports for audit and monitoring results. Notify appropriate authorities of major violations.

  • Comply with ICH Good Clinical Practice, IRB, and NCI Coordinating Center policies and procedures. Will instruct and train research personnel assigned to multi-center trials in these guidelines and practices.

  • Works closely with PI, study biostatistician, Coordinating Center Clinical Research Manager, and other Clinical Research Office (CRO) members to develop electronic case report forms (i.e., REDCap) and study calendars.

  • Review study documents, prepare for JHM IRB submissions and other regulatory agencies such as NCI, FDA, and ClinicalTrials.gov

Classified Title: Clinical Research Coordinator

Job Posting Title (Working Title): Research Program Coordinator (Oncology)

Role/Level/Range: ACRO37.5/03/CD

Starting Salary Range: $17.20 - $30.30 HRLY ($19-$22hour targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon-Fri

FLSA Status: Non-Exempt

Location: Hybrid: On-site 3-4 days a week

Department name: SOM Onc Clinical Research Office

Personnel area: School of Medicine

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.