The Department of Medicine - Division of Hematology is seeking a Research Program Coordinator (RPC) to be responsible for monitoring and collecting research data for sickle cell disease. The 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 on protocol implementation and collection of clinical research information. The coordinator will help with consenting research participants, collecting research samples and delivering them to the lab, and preparing monthly data reports for 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. The position will work under the direct supervision of the Research Program Manager,

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.
• Become knowledgeable of and comply 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.

Additional Knowledge, Skills & Abilities

• Excellent organizational skills.
• Excellent attention to detail skills.
• Demonstrated ability to manage multiple and competing priorities.
• Excellent time management skills.
• Excellent oral and written communication skills.
• Proven ability to work independently.

• Bachelor's degree in related discipline.
• Additional related experience may substitute for required education, 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 ($52,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8:30a - 5p 
Exempt Status: Non-Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Hematology  
Personnel area: School of Medicine