Sr. Clinical Research Coordinator (Neurology)

plans. Contributes to budget formulation, communications, and data systems.

Specific Duties & Responsibilities

• Assist Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol/study design.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for clinical trials based on protocol(s).
• Prepare materials for submission to IRB.
• Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services.
• Ensure compliance with all protocols, procedures, and applicable regulations.
• Participate in developing the study budget.
• Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies.
• Set up a data collection system and ensure the validity of study data.
• Organize and quality control study data
• Perform self-audits and/or audit other sites.
• Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Other duties as assigned.

In addition to the duties above:

• Independently execute all protocol-related activities, including study visit scheduling, pending study drug orders to providers, procuring study drug from Investigational Drug Service, patient assessments, sample processing and shipping and data collection
• Manage all regulatory documentation
• Enter study data into Electronic Data Capture Systems.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Three years of related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master's Degree in a related field.

Technical Skills & Expected Level of Proficiency

• Budget Management - Developing
• Clinical Research Participant Recruitment - Developing
• Clinical Study Design - Developing
• Clinical Trial Management System - Developing
• Data Management and Analysis - Developing
• Data Collection and Reporting - Developing
• Good Clinical Practices - Developing
• Interpersonal Skills - Developing
• Project Management - Developing
• Regulatory Compliance - Developing
• Report Writing - Developing

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Classified Title: Sr. Clinical Research Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $42,330 - $74,110 Annually ($58,220 Targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Neuro Neuromuscular
Personnel area: School of Medicine