Sr. Clinical Research Coordinator (Health, Behavior and Society)

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Coordinator oversees the day-to-day activities of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple clinical research studies and makes independent decisions that impact the conduct of the research. Assists in goal setting and creating implementation 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

• Trains, oversees, and monitors participant recruitment and enrollment efforts including obtaining informed consent.
• Oversees scheduling and conduct of participant visits throughout the US. Coordinates travel logistics and bookings for research assistants performing visits outside the local area.
• Tracks and monitors biospecimen deliveries and data uploads to central repositories
• Tracks and reports on study progress at lab and multisite field operations meetings
• Performs office related duties included but not limited to: answering phones, picking up and delivering mail, storing and distributing office supplies, handling faxes, scanning, filing, photocopying, collating materials, maintaining the update of study manuals, etc.

• 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.

• 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
Job Posting Title (Working Title):Sr. Clinical Research Coordinator (Health, Behavior and Society)
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually (Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday to Friday: 8:30am - 5:00pm
FLSA Status:Exempt
Location: School of Public Health
Department name: HBS-Research Projects
Personnel area: School of Public Health