Under the direct supervision of the Research Program Manager, the Department of Medicine is seeking a Research Program Coordinator who will be responsible for monitoring and collecting research data for sickle cell disease in the Division of Hematology. The Research Program Coordinator (RPC) 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. The coordinator will help with consenting, collecting research samples and delivering them to the lab, and helping to prepare monthly data reports to the PI and collaborating investigators. The RPC may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an intermediate level position in managing research trials and registry databases within the research program.Specific Duties & Responsibilities
Oversee and conduct recruitment, screening and enrolling of eligible patients into laboratory protocols.
Explain the protocol in detail and conduct informed consent procedures with potential research participants.
Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction.
Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data.
Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed. Assist less experienced staff in design and creation of such forms.
Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication.
Design and compile materials which aid physicians/other staff in complying with protocol requirements.
Meet regularly with Principal Investigator to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management. Participate in data analysis as needed.
Meet with department financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Participate in the development of invoicing schedules.
Prepare for and participate in monitoring and audits of studies. Write responses to audit reports with input from the Principal Investigator.
Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
Prepare and submit invoices to sponsors in a timely manner.
Work with Divisional finance staff to ensure that all invoice amounts are collected and reconciled periodically.
Perform all other duties as assigned.
Minimum Qualifications
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Excellent organizational skills required.
Excellent attention to detail skills required.
Proven ability to manage multiple and competing priorities.
Excellent time management skills.
Excellent oral and written communication skills.
Demonstrated ability to work well with other professionals with minimal supervision.
Classified Title: Research Program CoordinatorRole/Level/Range: ACRO40/E/03/CDStarting Salary Range: $17.00 - $30.00 HRLY ($50,000 targeted; Commensurate with experience)Employee group: Full TimeSchedule: m-f 8:30 - 5Exempt Status: Non-ExemptLocation: Hybrid/School of Medicine CampusDepartment name: SOM DOM HematologyPersonnel area: School of MedicineEqual Opportunity Employer:Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.
