* 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

-Bachelors Degree OR equivalent training acquired via work experience or education
-Less than one year of previous job-related experience .

- 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

Bachelors Degree OR equivalent training acquired via work experience or education

Proficient in Microsoft Office suite.
REDcap proficiency preferred

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.

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.