CLINICAL PROTOCOL COORDINATOR

Job description

Position Details

Job 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

Regulatory 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.

Minimum Education and/or Work Experience

Minimum Education:
Required: Bachelors Degree OR equivalent training acquired via work experience or education
Preferred: Bachelors Degree
Specify Degree(s): Bachelor of Science

Minimum Experience:
Required: Less than one year of previous job-related experience
Preferred: 1-2 years of previous job-related experience
Details: Clinical trials experience

Qualifications

-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

Certificates/Credentials/Licenses

Required: fluent in Spanish

Computer 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.

Supervisory ResponsibilitiesNoRequired operation of university owned vehiclesNoDoes this position require direct animal or patient contact? Physical DemandsNoneWorking ConditionsIrregular HoursOpen Date09/29/2020Close DateSpecial Instructions to ApplicantsQuick Link for Postinghttp://www.careers.luc.edu/postings/14333Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Public Job Posting
    • Internal Job Posting
    • Agency Referral
    • Advertisement/Publication
    • Personal Referral
    • Website
    • Other
  2. * Why do you want to work for Loyola University Chicago?

    (Open Ended Question)

  3. * What is the highest level of education you have completed?
    • High School Diploma or Equivalent
    • Bachelor's Degree
    • Master's Degree
    • PhD or Equivalent
  4. * How many years of relevant experience do you have?
    • 0-1 years
    • 1-3 years
    • 3-5 years
    • 5+ years
Applicant DocumentsRequired Documents
  1. Resume
  2. Cover Letter/Letter of Application
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    Job No:
    Posted: 10/15/2020
    Application Due: 12/14/2020
    Work Type:
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