• Research Program Coordinator - #Staff

    Johns Hopkins University (Baltimore, MD)


    The Department of Surgery, Cardiac division is seeking a **Research Program Coordinator** that will be responsible to coordinate several sponsored clinical studies related to cardiac surgery. This role is a critical component of the success of the cardiac surgery clinical trials program. The position will coordinate the implementation of research protocols, as well as ongoing administrative processes related to these studies. This includes screening and enrolling patients, providing continued monitoring of these studies, and ensuring that all protocols are followed. Additionally, the position will oversee status reporting, billing, and other regulatory components to ensure accurate execution.

    Specific Duties & Responsibilities:

    + Coordinate duties pertaining to opening new trials.

    + Handle relevant patient biological specimens and follow protocol requirements. Provide support and coordination for fellows and physicians during the planning phases of new trials. This includes protocol, consent, and case report form development through enrollment, study completion, and post-study closure.

    + Accountable for the overall administration and outcomes for trials requiring advanced-level knowledge and skills to manage a diverse portfolio of research responsibilities.

    + Daily screening, recruitment, protocol adherence, scheduling patient visits and assessments, as well as in-person and telephone follow-ups.

    + Blood sample processing to include obtaining specimens by phlebotomy and appropriate handling and labeling.

    + Regular attendance at research meetings, as well as providing updates on the study progress and issues related to the research.

    + Prepare regulatory reports and maintain all regulatory binders for enrolling trials and trials in the follow-up phase.

    + Prepare and maintain individual participant study binders.

    + Assist with the preparation of IRB submissions.

    + Adhere to FDA regulatory compliance and regulations.

    + Maintain appropriate correspondence with the IRB. Complete and submit IRB Change in Research Reports, including adverse events, protocol deviations, and protocol amendments.

    + Complete and submit annual IRB continuing review reports.

    + Ensure quality, consistency, and accuracy in the conduct of research trials.

    + Maintain appropriate correspondence with the external Sponsors.

    + Maintain research databases, including data entry and management.

    + Assist in clinical trial design.

    + Assist with obtaining consent from study participants and documenting the consent process.

    + Assist in data collection, including patient contact for enrollment and follow-up.

    + Oversee record management for several research studies. Set up database, as well as processing systems and efficiencies for reporting purposes using Excel, Access, or similar systems.

    + Oversee budget development, as well as budget expenditures for study operations.

    + Conduct all study close-out related procedures, including IRB termination reports.

    Minimum Qualifications

    + Bachelor's Degree in related discipline.

    + Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.

     

    Classified Title: Research Program Coordinator

    Role/Level/Range: ACRO40/E/03/CD

    Starting Salary Range: $17.20 - $30.30 HRLY ($43,000 targeted; Commensurate w/exp.)

     

    Employee group: Full Time

     

    Schedule: M-F 9 am - 5:30 pm

     

    FLSA Status: Non-Exempt

     

    Department name: SOM Sur Cardiac Surgery

    Personnel area: School of Medicine

    The listed salary range represents the minimum and maximum Johns Hopkins University offers for this position, based on a good faith estimate at the time of posting. Actual compensation will vary depending on factors such as location, skills, experience, market conditions, education, and internal equity. Not all candidates will qualify for the highest salary in the range.

     

    Johns Hopkins provides a comprehensive benefits package supporting health, career, and retirement. Learn more: https://hr.jhu.edu/benefits-worklife/.

     

    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