Sr. Clinical Research Coordinator (Psychiatry and Behavioral Sciences)

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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. Bayview Geriatric & Neuropsychiatry is seeking a 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 described above
Oversee collection and shipping of blood to national repository.
Conduct comprehensive clinical and cognitive assessments of research participants in accordance with study protocols and standardized procedures.
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.
Proficiency in coordination of tasks across multiple research teams.
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.
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Location: Johns Hopkins Bayview
Department name: SOM Psy Bay BV Geriatric and Neuropsychi
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Skills
Clinical Research, Project Management, Quality Control, Regulatory Compliance

Experience
3+ yrs