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 requires all Health Sciences Campus Faculty and Staff to be vaccinated with the original COVID -19 and Flu vaccines when eligible. An e xemption for a qualified medical or religious reason may be submitted for review/approval.
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 . 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 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/24023
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Higher Education
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