The Department of Neurology’s Multiple Sclerosis Precision Medicine Center of Excellence (MS PMCOE) is seeking a full time Sr. Research Program Coordinator. The Sr. Research Program Coordinator will be responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials. The Sr. Research Program Coordinator will also be responsible for the identification and recruitment of study participants, including attending clinic as necessary, coordination and/or collection and analysis of data, including imaging (e.g., OCT, MRI) and specimens (e.g., blood), organizing regulatory paperwork, and assisting with manuscript preparation. The Sr. Research Program Coordinator will work directly with the principal investigators and other study coordinators to develop, amend, and execute study protocols. The Sr. Research Program Coordinator will also monitor, schedule, and execute participant study visits and monitor the study budget. The Sr. Research Program Coordinator will assist with orientation of less senior research staff in protocol and clinical research information. This position reports to the division’s Sr. Research Program Manager, with an indirect reporting line to the faculty principal investigators of the clinical research projects.
Specific duties & responsibilities:
Maintains good working knowledge of all assigned protocols and reporting requirements.
Adheres to all protocol and regulatory requirements to ensure the validity of the clinical research data.
Works on complex clinical studies which require a high level of knowledge, coordination, and attention to detail.
Maintains regulatory binder for each assigned protocol. Prepares and submits IRB and Sponsor correspondences (e.g., continuing reviews, changes in research, adverse event reporting).
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.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Maintains a research chart for each patient; Collects, enters and compiles clinical data, including imaging and bio specimens.Ensures accuracy and timeliness of data for use in presentations and publications.
Meets regularly with Principal Investigator and other study team members to review data accuracy and overall study progress; participates in all other meetings.
Will develop and maintain a system for tracking patient activity, financial management, including invoicing, and data analysis as needed.
Assists with study budget and invoice preparation as needed.
Assist the Principal Investigator in preparing for audits.
Other duties as assigned.
Bachelor's degree in Biological/Social Sciences or other appropriate discipline required. Three years of related experience required. Proficiency in the use of software applications, databases, spreadsheets, and word processing required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Experience in clinical research preferred. Experience using REDCap
Special knowledge, skills, and abilities:
Must exhibit excellent attention to detail and skills in organization and communication. Must have a professional attitude and mature outlook. Must be self-motivated and able to work independently to complete tasks and work well with others.
Technical qualifications or specialized certifications:
Experience using Microsoft Word and Excel.
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920-$53,520 Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003522-SOM Neuro Neuroimmunology Personnel area: School of Medicine
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