Research Program Assistant II

General summary/purpose: The Research Program Assistant II will be responsible for the logistics of enrolling patients into clinical research studies investigating peripheral neuropathies and types of myositis and their underlying causes and treatments.

Specific duties & responsibilities:

Clinical Research Activities

• Assist the principal investigator with multiple clinical research projects. Work on clinical studies requiring a high level of knowledge, coordination and data abstraction
• Assist clinicians with patient screening, consenting and verification of patient eligibility for studies
• Explain protocol procedures and obtain informed consent
• Schedule patients’ appointments and follow up visits/phone calls at the appropriate time to assure completion of protocol requirements, which may require coordination of multiple appointments and centers.
• Be responsible for organization, entry, maintenance and accuracy of patient clinical research data
• Design and compile materials which aid physicians and other staff in complying with protocol requirements
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
• Responsible for monitoring the clinical course and collection of research data on patients entered into research protocols
• Collect patient source documents and case report forms for analyzing patient data.
• Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus
• Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study and ensure integrity of data collected
• Coordinate the collection and documentation of patient information for research purposes.
• Organize and create clinical research charts to be reviewed by regulatory agencies
• Maintain a research database of patients enrolled in clinical trials
• Participate in and or organize community events to increase public awareness

Regulatory Compliance

• Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements
• Maintain regulatory binders per protocols
• Document adverse events and protocol deviations
• Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements

Data Management

• Responsible for maintaining and promptly updating online Clinical Research Management System
• Assist with preparation of data for reports and presentations
• Respond in a timely manner to special projects or queries related to data
• Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process
• Perform quality checks on data entry
• Ensure accuracy and timeliness of data collection. Interact regularly and helps facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies
• Abstract patient clinical and demographic from a variety of sources and enter into tracking spreadsheet or data base

Scholarly Activities

• Assist with writing manuscripts and abstracts for publication
• Assist with development of grants, progress reports and study protocols

Research Program Oversight

• Meet regularly with Principal Investigators to review data accuracy and overall study progress
• Work with the Center Directors and/or study sponsors on problem recognition/resolution, accuracy of data gathered and patient well-being, completion and collection of regulatory documents required by sponsors
• Prepare for and participates in audits of studies including follow-up items
• Conduct periodic audits under the direction of the Program Coordinator and/or PI

Financial Management

• Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials

Minimum qualifications (mandatory):

• Requires high school diploma/GED and minimum of two years related experience.
• Additional education may substitute for experience to the extent permitted by the JHU equivalency formula.

Preferred qualifications: