The Department of Medicine, Division of Hematology is seeking a part-time Research Program Coordinator who will be responsible for monitoring and collecting research data for sickle cell disease research. The 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 new, less experienced staff to protocol and clinical trial information. The coordinator will help with consenting, collecting research samples and delivering them to the lab, and preparing monthly data reports for the PI and collaborating investigators.

Specific Duties & Responsibilities

• Oversee and conduct recruitment, screening and enrollment 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 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 physicians in treatment planning for individual patients, and by the Principal Investigator in grant writing, presentations and publication.
• Design and compile materials which aid physicians/other staff in complying with protocol requirements.
• Meet regularly with the 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 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.
  

• 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.
• Be 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.
• Perform all other duties as assigned.
  

Additional Knowledge, Skills, & Abilities

• Excellent organizational skills
• Excellent attention to detail skills
• Ability to manage multiple and competing priorities.
• Excellent time management skills.
• Excellent oral and written communication skills.
• Able to work independently.
• Ability to work well with other professionals with minimal supervision and be comfortable being part of a diverse professional team.

• 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 ($24,700 targeted; Commensurate with experience) 
Employee group: Part-time 
Schedule: M-F 20 Hours per Week 
Exempt Status: Non-Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Hematology  
Personnel area: School of Medicine