Sr. Clinical Research Coordinator (SOM - Pediatric Infectious Disease)

School of Medicine Pediatric Infectious Disease is seeking a Sr. Clinical Research Coordinator. The Sr. Clinical Research Coordinator oversees the day-to-day activities of multiple government funded and pharmaceutical research trials and makes independent decisions that impact the conduct of the research. The candidate will work collaboratively with a multidisciplinary health care/research team to promote quality and excellence of care, optimize team performance, and achieve divisional clinical, research and organizational goals and outcomes. The Sr. Clinical Research Coordinator is the primary individual responsible for coordinating and conducting participant study visits for their assigned protocols.

The Eudowood Trials Network researchers conduct pediatric focused clinical trials and clinical studies that promote access to innovative therapeutics and diagnostics; effectively advancing pediatric clinical care and treatment in the specialty populations of infectious disease, pulmonology, and neonatology.

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.
• Use appropriate electronic systems for clinical trial management.
• Direct the research staff and coordinate activities of the study visit at the clinical research unit, mobile research van, community venues, and participant homes.
• Performs, and/or monitors procedures & tests per protocol requirements.
• Recognize and document adverse events per protocol & ensure reporting to appropriate study & regulatory personnel.
• Ensure compliance with all protocols, procedures, and applicable regulations.
• Participate in developing the study budget and provides information for study billing.
• 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.
• Participate in study meetings, provide staff education, communicate 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 responsibilities described above

• Manage inventory and prepare space for study-related equipment & supplies.
• Attend and participate in in-service and external training, workshops, conferences, and other relevant and/or required programs for professional growth and development.

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.
• Understanding of the Epidemiologic and clinical aspects of HIV infection and sensitivity to the Psychological, Social, and medical needs of people living with HIV.
• Prior coursework in Biology, Microbiology, or Infectious Diseases is desirable.

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: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F; 8:30 - 5pm
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Ped Infectious Disease
Personnel area: School of Medicine