Loyola University Chicago Maywood, IL, USA
Jan 09, 2020Full time
Duties & Responsibilities Regulatory responsibilities: - Processes local IRB submissions to include new research projects, amendments, adverse events and terminations. - Processes FDA submissions. Establishes and maintains research project’s regulatory files. - Performs ongoing communication with local IRB, federal organizations, affiliate institutions and pharmaceutical study sponsors. Performs ongoing communications within the research team regarding research project changes. Specimen Handling and Shipping: - Coordinates with Clinical Research RN to organize procurement and preparation, packaging and shipping of research samples. - Manages research sample supplies. Data Management: - Collects, records and maintains accurate data reporting adhering to protocol data collection guidelines. Clarifies data queries. Prepares long term reporting. - Prepares and participate in Cooperative Group Audits, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits. - Participates in Departmental Process Improvement Activities, National Committees as appropriate. - Participates in program research planning to include as appropriate, protocol development, data reporting and grant reporting. - Performs other duties as assigned. Minimum Education and/or Work Experience Minimum Education: Required: Bachelors Degree OR equivalent training acquired via work experience or education Preferred: Bachelors Degree Specify Degree(s): Bachelor of Science Minimum Experience: Required: Less than one year of previous job-related experience Preferred: 1-2 years of previous job-related experience Details: Clinical trials experience Qualifications - Experience with oncology population preferred. - Project management skills. - Excellent written and verbal communication skills. - Experience working in clinical trials highly desirable. Computer Skills Computer literacy with word processing, Excel, internet, databases, electronic data capture.