• Sr. Research Program Coordinator - #Staff

    Johns Hopkins University (Baltimore, MD)


    Under the direct supervision of the GU Clinical Research Program Manager or the Principal Investigator, we are seeking a **_Sr. Research Program Coordinator_** who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and participating sites. The Sr. Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials and may assist with orientation of less senior research staff in protocol and clinical research information. This is an intermediate level position in managing clinical trials and/or registry databases within the GU Oncology Program.

    Specific Duties and Responsibilities

    + Maintains good working knowledge of all assigned protocols and reporting requirements. Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.

    + Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, according to IRB and Sponsor requirements.

    + May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. Will design and create protocol specific case report forms as needed. May also assist less experienced staff in design and creation of such forms.

    + Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review regulatory accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.

    + Prepares for and participates in monitoring and audits of studies. Corrects errors when necessary. Writes responses to audit reports with input from the Principal Investigator.

    + Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies. May instruct introductory level clinical research personnel in these guidelines and policies.

    + Assists with study budget and invoice preparation as needed.

    Specific Duties and Responsibilities for GU Oncology Senior Research Program Coordinator

    + Ensures smooth implementation of new trials from IRB approval through study activation including collection of regulatory documentation for Sponsor and Investigator initiated studies.

    + Working closely with Sponsors and Investigators, will submit and track each assigned protocol amendment through the IRB/subcommittee approval process, revise RedCap database as applicable and update all manuals and documents pertaining to the amendment.

    + Assist in ongoing reviews of all regulatory binders to ensure that documents are up to date and meet all Sponsor, protocol and Cancer Center requirements. Will work with lead study coordinators, research nurses and investigators to address issues identified in the review of regulatory binders.

    + Maintain central regulatory files for all staff including licenses, master delegation logs, CV’s and IRB training documents for Good Clinical Practice.

    Minimum Qualifications

    + Bachelor's Degree in related discipline.

    + Three years related experience.

    + 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: Sr. Research Project Coordinator

     

    Job Posting Title (Working Title): Sr. Research Program Coordinator

    Role/Level/Range: ACRP/03/MB

    Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate w/exp.)

     

    Employee group: Full Time

     

    Schedule: Mon - Fri / 8:30a - 5p

     

    FLSA Status: Exempt

     

    Department name: 10002941-SOM Onc Urologic Oncology

    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