CLINICAL PROTOCOL COORDINATOR
CLINICAL PROTOCOL COORDINATORPosition Number:
University StaffJob Type:
Maywood-Health Sciences CampusDepartment Name:
CLINICAL RESEARCH OFFICELocation Code:
CLINICAL RESEARCH OFFICE (06124A)Is this split and/or fully grant funded? :
NoDuties 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.
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, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.
- Performs related duties as assigned.
Required: Bachelors Degree OR equivalent training acquired via work experience or education
Preferred: Bachelors Degree
Specify Degree(s): Bachelor of Science
Required: Less than one year of previous job-related experience
Preferred: 1-2 years of previous job-related experience
Details: Clinical trials 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
NoRequired operation of university owned vehicles:
02/11/2021Quick Link for Posting: