Clinical Protocol Coordinator

  • Loyola University Chicago
  • Maywood, IL, USA
  • Jan 09, 2020
Full time Health Care Research

Job Description

Duties & Responsibilities

Regulatory responsibilities:
- Processes local IRB submissions to include new research projects, amendments, adverse events and terminations.
- Processes FDA submissions. Establishes and maintains research project’s regulatory files.
- Performs ongoing communication with local IRB, federal organizations, affiliate institutions and pharmaceutical study sponsors. Performs ongoing communications within the research team regarding research project changes.

Specimen Handling and Shipping:
- Coordinates with Clinical Research RN to organize procurement and preparation, packaging and shipping of research samples.
- Manages research sample supplies.

Data Management:
- Collects, records and maintains accurate data reporting adhering to protocol data collection guidelines. Clarifies data queries. Prepares long term reporting.
- Prepares and participate in Cooperative Group Audits, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.
- Participates in Departmental Process Improvement Activities, National Committees as appropriate.
- Participates in program research planning to include as appropriate, protocol development, data reporting and grant reporting.
- Performs other 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

- Experience with oncology population preferred.
- Project management skills.
- Excellent written and verbal communication skills.
- Experience working in clinical trials highly desirable.

Computer Skills

Computer literacy with word processing, Excel, internet, databases, electronic data capture.