CLINICAL PROTOCOL COORDINATOR
Position DetailsJob TitleCLINICAL PROTOCOL COORDINATORPosition Number8150706Job CategoryUniversity StaffJob TypeFull-TimeFLSA StatusNon-ExemptCampusMaywood-Health Sciences CampusDepartment NameCLINICAL RESEARCH OFFICELocation CodeCLINICAL 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.
- 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
-Fluent in Spanish
- 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
Required: fluent in SpanishComputer Skills
• Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon.
• Clinical Trials Management System.
• Electronic data entry web based data bases.
Required fields are indicated with an asterisk (*).
- * How did you hear about this employment opportunity?
- Public Job Posting
- Internal Job Posting
- Agency Referral
- Personal Referral
- * Why do you want to work for Loyola University Chicago?
(Open Ended Question)
- * What is the highest level of education you have completed?
- High School Diploma or Equivalent
- Bachelor's Degree
- Master's Degree
- PhD or Equivalent
- * How many years of relevant experience do you have?
- 0-1 years
- 1-3 years
- 3-5 years
- 5+ years
- Cover Letter/Letter of Application