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　　Position Details

　　Position Details

　　Job Title CLINICAL RESEARCH COORDINATOR I

　　Position Number 8150814

　　Job Category University Staff

　　Job Type Full-Time

　　FLSA Status Non-Exempt

　　Campus Maywood-Health Sciences Campus

　　Department Name CBCC Research

　　Location Code CBCC RESEARCH (06310A)

　　Is this split and/or fully grant funded? Yes

　　Duties and 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.

　　Collects, records and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines.

　　Clarifies Data Queries.

　　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.

　　Minimum Education and/or Work Experience

　　.

　　Qualifications

　　Ability to follow oral and written instructions and established procedures.

　　Ability to perform basic filing, office procedures and word processing.

　　Ability to maintain accuracy and consistency.

　　Ability to communicate verbally.

　　Ability to finish tasks in a timely manner.

　　Ability to maintain confidentiality.

　　Ability to compose letters and memorandums.

　　Ability to deal calmly and courteously with people.

　　Ability to analyze and interpret data.

　　Ability to function independently and manage own time and work tasks.

　　Ability to work as an effective team member.

　　Ability to organize workflow.

　　Ability to negotiate, persuade and establish direction.

　　Ability to maintain office files and follow standard office procedures.

　　Skilled job requiring high level of adaptability & interpersonal skills.

　　Ability to interact with internal and external constituents.

　　Certificates/Credentials/Licenses

　　CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP ) is desired

　　Computer Skills

　　Proficiency with Microsoft Word, Groupwise, EPIC , Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon.

　　Clinical Trials Management System.

　　Electronic data entry web based data bases.

　　Supervisory Responsibilities No

　　Required operation of university owned vehicles No

　　Does this position require direct animal or patient contact? No

　　Physical Demands None

　　Working Conditions None

　　Open Date 01/11/2024

　　Close Date

　　Special Instructions to Applicants

　　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 diversity, equity, and inclusion (https://www.luc.edu/diversityandinclusion/) . 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 benefits (https://cld.bz/c/sy7N6a?utm_medium=email&utm_source=transactional&utm_campaign=CldBz-Share-Collection) 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.

　　Quick Link for Posting https://www.careers.luc.edu/postings/27265