Clinical Research Coordinator II (SOM Ped Infectious Disease)

Clinical Research Coordinator II

The School of Medicine, Pediatric Infectious Diseases is seeking a Clinical Research Coordinator II to administratively coordinates the day-to-day activities of multiple government funded and pharmaceutical research trials. Will ensure efficient logistical implementation of study activities in a variety of venues (i.e., research unit, inpatient unit, mobile van, participant homes, etc.) and provide administrative support for research-related regulatory issues. 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 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 Clinical Research Coordinator II administratively coordinates clinical protocol implementation 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 studies. Will ensure efficient logistical implementation of study activities and provide administrative support for research-related regulatory issues.

Specific Duties & Responsibilities

• Coordinate all activities of a complex clinical research study or multiple studies to ensure adherence to protocol and validity of findings.
• Participate in clinical study start-up meetings.
• Assist research nurses, study coordinators, principal investigators, and other study personnel in executing protocol-related activities.
• Explain the study background and rationale for the research to potential and current participants.
• Contribute to the development of recruitment strategy for participants for one or more assigned studies.
• Implement a variety of techniques for recruitment as appropriate, e.g., print and web-based advertisements, contact referring physicians, participate in community events, etc.
• Independently conduct the consenting process or ensure consent is obtained on appropriate participants.
• Schedule participants for multiple required activities e.g., laboratory tests, visits, procedures, and treatment and resolve any schedule conflicts and ensure timely participant tracking.
• Serve as liaison to study participants
• Assist with setup of data collection system(s) and enter and organize data.
• Assist in coordinating study meetings.
• Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.
• Assist with preparation of submissions to the Institutional Review Board (IRB)
• Liaison with IRB on administrative matters and facilitate communications with the PI(s).
• Track/maintain regulatory documentation and clinical care documentation provided to increase regulatory compliance.
• Serve as a resource for clinicians involved in the study regarding protocol requirements.
• Conduct literature searches to provide background information. Abstract, index, and analyze information.
• Obtain required samples and collaborate with internal and external entities for studies involving procurement and processing of clinical samples
• Obtain and maintain excellent operating knowledge of assigned clinical protocols, clinical equipment, and clinical computer systems.
• Oversee budget expenditures for study operations.
• Ensure adequate study supplies are ordered and maintained, e.g., shipping, laboratory, office, specimen handling, etc.
• May train and/or oversee other non-exempt study staff.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree in related field.
• One year 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

Technical Skills & Expected Level of Proficiency

• Budget Management - Developing
• Clinical Research Participant Recruitment - Developing
• Clinical Research Knowledge - Developing
• Clinical Trial Management System - Developing
• Data Collection and Reporting - Developing
• Good Clinical Practices - Developing
• Information Gathering - Developing
• Interpersonal Skills - Developing
• Project Coordination - Developing
• Regulatory Compliance - Developing

Classified Title: Clinical Research Coordinator II
Role/Level/Range: ACRO40/E/03/CE
Starting Salary Range: $19.75 - $35.35 HRLY ($55,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F; 8:30 - 5:00
FLSA Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Ped Infectious Disease
Personnel area: School of Medicine