Job Title | CLINICAL RESEARCH COORDINATOR I |
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Position Number | 8150113 |
Job Category | University Staff |
Job Type | Full-Time |
FLSA Status | Non-Exempt |
Campus | Maywood-Health Sciences Campus |
Department Name | CBCC RESEARCH |
Location Code | HEMATOLOGY - ONCOLOGY (06508A) |
Is this split and/or fully grant funded? | Yes |
Duties and Responsibilities | * Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines. * Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. * Coordinate collection of study specimens and processing. * Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. * Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. * Participate in monitor visits and regulatory audits. Regulatory responsibilities: * Establish and maintain research project's regulatory files * Ongoing communication with the local IRB, federal organizations, affiliate institutions and pharmaceutical study sponsors. 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, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits. * Performs related duties as assigned |
Minimum Education and/or Work Experience | -Bachelors Degree OR equivalent training acquired via work experience or education -Less than one year of previous job-related experience . |
Qualifications | - 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 terminology - Phlebotomy skills required for CRO |
Certificates/Credentials/Licenses | Bachelors Degree OR equivalent training acquired via work experience or education |
Computer Skills | Proficient in Microsoft Office suite. REDcap proficiency preferred |
Supervisory Responsibilities | No |
Required operation of university owned vehicles | No |
Does this position require direct animal or patient contact? | No |
Physical Demands | Repetitive Motions |
Working Conditions | Irregular Hours |
Open Date | 03/09/2023 |
Close Date | |
Special Instructions to Applicants |
Loyola all Health Sciences Campus Faculty and Staff to be with the original COVID-19 and Flu vaccines when eligible. An e for a qualified medical or religious reason may be submitted for review/approval.
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Diversity and Inclusion Statement | Diversity, Equity, and Inclusion
As one of the nation's largest Jesuit, Catholic universities, Loyola University Chicago fosters a transformative cultural experience that honors . We are committed to not only recruiting, but also retaining a diverse, mission driven workforce and enabling a culture of inclusiveness in an environment that values service excellence, stewardship, personal well-being, and professional development for all of our employees. Loyola University Chicago supports its staff and faculty with a wide array of affordable, comprehensive and competitive centered on health and wellness, financial security, equity, and work-life balance. We actively seek those who wish to join our faculty, staff, and students in a community of diverse opinions, perspectives, and backgrounds supporting our Jesuit mission and striving toward the same goal of being persons for and with others.
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