CLINICAL PROTOCOL COORDINATOR

Hispanic Outlook


Job Description
Regulatory responsibilities:- Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations.- Processes FDA submissions Establish and maintain research project's regulatory files- Ongoing communication with the local IRB , federal organizations, affiliate institutions and pharmaceutical study sponsors.- Ongoing communication within the research team regarding research project changes.Data Management Responsibilities:- Collects, records and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarifies Data Queries.Specimen Handling and Shipping Responsibilities:- Coordinates with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples. Manages research sample supplies- Participates in Cooperative Group Audits, NCI , FDA , Sponsor GCP quality audits, Loyola internal audits and department audits.- Performs related duties as assigned.FLSA StatusNon-ExemptDepartment NameCLINICAL RESEARCH OFFICEIs this split and/or fully grant funded?NoMinimum Education and/or Work ExperienceMinimum Education:Required: Bachelors Degree OR equivalent training acquired via work experience or educationPreferred: Bachelors DegreeSpecify Degree(s): Bachelor of ScienceMinimum Experience:Required: Less than one year of previous job-related experiencePreferred: 1-2 years of previous job-related experienceDetails: Clinical trials experienceQualifications- Ability to analyze and interpret data- Ability to communicate verbally- Ability to compose letters and memorandums- Ability to deal calmly and courteously with people- Ability to finish tasks in a timely manner- Ability to follow oral and written instructions and established procedures- Ability to function independently and manage own time and work tasks- Ability to maintain accuracy and consistency- Ability to maintain confidentiality- Ability to maintain office files and follow standard office procedures- Ability to negotiate, persuade and establish direction- Ability to organize workflow- Ability to perform basic filing, office procedures and word processing- Ability to work as an effective team member- Knowledge of medical terminologyCertificates/Credentials/LicensesN/AComputer SkillsN/ASupervisory ResponsibilitiesNoRequired operation of university owned vehiclesNoDoes this position require direct animal or patient contact?YesPhysical DemandsNoneWorking ConditionsNone
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