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Under the direct supervision of the Sr. Research Program Supervisor or Nurse Manager, we are seeking a **_Research Program Coordinator_** who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols in the Department of Hematologic Malignancies. Responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This data will be used to generate specific study findings after the data is analyzed.

Specific Duties & Responsibilities

+ Maintains good working knowledge of all assigned protocols and reporting requirements.

+ Transmits and distributes protocol information.

+ Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library and the Clinical Research Management System.

+ Maintains study binder for each assigned protocol with patient specific documents.

+ Prepares and submits annual renewal requests, monitoring reports and adverse event reports with clinical input according to IRB and Sponsor requirements.

+ Adheres to all protocol requirements to ensure the validity of the clinical research data.

+ Manages and coordinates patients on trials which can include ordering, scheduling, patient interactions/assessments, and data input.

+ Assists with consenting study participants and documenting the consent process.

+ Coordinates initial clinical trial study documents for review and approval by central laboratory services.

+ Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.

+ Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.

+ When necessary, requests from outside institutions, pertinent patient records and tissue samples required for patient eligibility and monitoring while on study.

+ Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources.

+ Utilizing the study calendar, tracks patient progress and upcoming visits for accuracy.

+ Documents telephone and other communications with patients per institutional policy.

+ May assist with protocol submission to the IRB and other regulatory matters for study compliance.

+ Verifies and may assist with scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.

+ Meets regularly with members of the study team to review data accuracy and overall study progress.

+ Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.

+ Maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries.

+ Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.

+ Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data.

+ Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.

+ Completes minimum requirement for continuing educational units. Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.

Minimum Qualifications

+ Bachelor's Degree in related discipline.

Classified Title: Research Program Coordinator

Job Posting Title (Working Title): Research Program Coordinator

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

Starting Salary Range: $17.20 - $30.30 HRLY ($25.00/hour targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon - Fri / 8am - 4:30p

FLSA Status: Non-Exempt

Department name: 10002935-SOM Onc Hematologic Malignancies

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

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