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Research Program Coordinator

5 months ago

Baltimore, United States Johns Hopkins University Full time

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 is responsible for the organization, entry, maintenance and accuracy of research data for complex and detailed clinical trials which requires a high level of knowledge, coordination, and data abstraction. The coordinator will help with consenting participants, collecting research samples and delivering them to the lab, and preparing monthly data reports for the PI and collaborating investigators. The coordinator may assist in the development and writing of protocols and consent forms and the development and preparation of regulatory documents. Will clarify concerns and questions about new protocols with the PI and sponsor. This is an intermediate level position in coordinating 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.
- 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 PI 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.
- 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 PI in grant writing, presentations and publication.
- Design and compile materials which aid physicians/other staff in complying with protocol requirements.
- Meet regularly with PI 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 PI.
- 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.
- May assist with orientation of less senior research staff in protocol and clinical research information.
- Perform all other duties as assigned.

**Additional Knowledge, Skills and 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.
- Ability to work independently.

**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**

Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($40,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: m-f 8:30-5
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Hematology
Personnel area: School of Medicine