Sr. Research Program Supervisor

School of Medicine, Pediatric Hematology is seeking a Sr. Research Program Supervisor. Under the direct supervision of the Principal Investigator, the Sr. Research Program Supervisor is responsible for monitoring and collecting research data in the Division of Pediatric Hematology. The Sr. Research Program Supervisor is accountable 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 Sr. Research Program Supervisor will be a for the coordination and implementation of assigned research projects within the research program and will anticipate research requirements for designated patient populations. The Sr. Research Program Supervisor will also oversee and perform data analysis for departmental studies, grants, QI projects, and manuscripts. The Sr. Research Program Supervisor 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 Sr. Research Program Supervisor will also assist the PI with development of manuscripts, including analysis and preparations of tables and figures for presentations and publications. Will have responsibility for hiring and coaching research staff.

Specific Duties & Responsibilities

• Oversee and conduct recruitment, screening and enrolling of eligible patients into clinical 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 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.
• Use advanced knowledge of GraphPad Prism and other data analysis software to perform and oversee data analysis for departmental studies, grants, QI projects, and manuscripts.
• 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.
• 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.
• Prepares contract application and internal budgets for contracts administration.
• Acts as a liaison between pharmaceutical companies and the Department of Contracts Administration within the University.
• Conducts contract reviews to ensure they are executed properly in terms of budget analysis.
• Serves as central resource for clinical trials group, including the development of guidelines/templates for protocol development to ensure that all NIH, GCP, OHRP, JHU, and Federal regulations are followed in both the development and implementation of clinical trials.
• Creating consent forms, preparing IRB regulatory submissions, initiating and supervising study