- 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
Coordination 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.
- In collaboration with the PI & RN, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
- 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.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
- Ensure adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
- Regulatory responsibilities:
- Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations.
About Loyola University Chicago
Loyola University Chicago (Loyola or LUC) is a private Catholic research university in Chicago, Illinois. Founded in 1870 by the Jesuits, Loyola is one of the largest Catholic universities in the United States. Loyola's professional schools include programs in medicine, nursing, and health sciences anchored by the Loyola University Medical Center.
Comprising eleven colleges and schools, Loyola offers over 80 undergraduate and 140 graduate/professional programs and enrolls approximately 16,000 students. Loyola has six campuses across the Chicago metropolitan area, as well as a campus in Rome and guest programs in Beijing and Ho Chi Minh City. The flagship Lake Shore Campus is on the shores of Lake Michigan in the Rogers Park and Edgewater neighborhoods of Chicago, eight miles north of the Loop.
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