* 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