Sr. Clinical Research Coordinator

Researchers at Johns Hopkins University is seeking a Sr. Clinical Research Coordinator to 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.

Job Description Supplemental Information

This position is responsible for overseeing the Johns Hopkins arm of a large multicenter study known as Diverse VCID (DVCID). This involves coordination of activities among several cores of the Johns Hopkins Alzheimer’s Disease Research Center, as well as with the staff of the coordinating center at the University of California, Davis.
Coordinate acquisition of magnetic resonance imaging (MRI) scans and upload of scans to national repository.
Oversee collection and shipping of blood to national repository.

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 permitted by the JHU equivalency formula. 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. May require travel between several JHU sites.
Experience with clinical and cognitive evaluation of participants

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