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Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a
Clinical Research Coordinator II who will administratively coordinate 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.
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
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs. Classified Title: Clinical Research Coordinator II Role/Level/Range: ACRO40/E/03/CE Starting Salary Range: $19.75 - $35.35 HRLY ($45,000 targeted; Commensurate w/exp.) Employee group: Part-time Schedule: 24 Hours Per Week FLSA Status:Non-Exempt Location: Hybrid/School of Public Health Department name: Mental Health Research Projects Personnel area: School of Public Health
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