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Under the direct supervision of the Clinical Trial Manager with direction from the Principal Investigators, coordinates all aspects of assigned human subject research studies involving Spanish-speaking patients. Typically, responsible for the successful coordination of observational and clinical drug trials. Provides assistance to the other research coordinators and Principal Investigators, works as an integral part of the research team.
Job Responsibility:
Recruits, consents, schedules, and conducts research subject visits for observational studies
Meets with Spanish-speaking patients interested in research after their clinical visit to discuss research opportunities
Recruits and consents subjects to assigned research studies
Schedules and facilitates visits, performing study related procedures as outlined in protocol
May perform testing such as cognitive function tests, depending on protocol
Resolves questions and concerns received from study subjects, triaging to Principal Investigator as necessary
Monitors study progress on a continuous basis
Understands, implements, and provides training on most recent study protocol
Assists Spanish-speaking patients with research visit appointment confirmation and transportation facilitation
Manages the regulatory details for assigned research studies and registries
Prepares and/or maintains regulatory and study documentation
Manages and submits amendments and continuing reviews for IRB approval
Ensures compliance with all applicable regulatory and institutional requirements and standards
Trains with and assists other Human Subject Research Coordinators as directed on complex studies
Receives training and mentoring on conducting human subject research from HSRC II
Provides support with study visits, regulatory compliance, and queries
Assists with specimen processing and shipping
Serves as back-up research coordinator in the absence of the HSRC II
Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration
Maintains continuous communication with all relevant stakeholders
Resolves issues in a timely manner
Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol
Represents the University and Principal Investigator at study meetings as needed
Develops and/or manages databases for research studies and registries
Ensures data is entered in a timely manner, accurate, and database(s) is up-to-date
Responds to queries resulting from research visits in a timely manner, ensuring all issues are resolved
Demonstrates accountability for initial and ongoing learning related to clinical research studies
Keeps current with study-specific training
Attends training sessions and other educational opportunities related to clinical research
Attends division and research meetings
Attends and leads talks with community groups such as the Ibero-American Action League
Participates in Ibero’s community advisory board
Partners with the Latino Health Coalition
Requirements:
Bachelor’s degree Required
OR Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee Program Required
Or equivalent combination of education and experience Required
Fluent in the Spanish language (verbal & written) Preferred
Prior experience as a Phlebotomist Preferred
Word processing and data analysis software Preferred
Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software Preferred
Excellent communication skills, strong attention to detail, and strong interpersonal skills Preferred
Ability to work independently and as part of a team Preferred
Association of Clinical Research Professionals (ACRP) upon hire Preferred
Nice to have:
Fluent in the Spanish language (verbal & written)
Prior experience as a Phlebotomist
Word processing and data analysis software
Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software
Excellent communication skills, strong attention to detail, and strong interpersonal skills
Ability to work independently and as part of a team
Association of Clinical Research Professionals (ACRP) upon hire