CLINICAL PROTOCOL COORDINATOR
Position DetailsJob TitleCLINICAL PROTOCOL COORDINATORPosition Number8150114Job CategoryUniversity StaffJob TypeFull-TimeFLSA StatusNon-ExemptCampusMaywood-Health Sciences CampusDepartment NameONCOLOGY INSTITUTELocation CodeONCOLOGY INSTITUTE (06310A)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.
•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: Bachelor’s Degree OR equivalent training acquired via work experience or education
Preferred: Bachelor’s 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 follow oral and written instructions and established procedures.
•Ability to perform basic filing, office procedures and word processing.
•Ability to maintain accuracy and consistency.
•Ability to communicate verbally.
•Ability to finish tasks in a timely manner.
•Ability to maintain confidentiality.
•Ability to compose letters and memorandums.
•Ability to deal calmly and courteously with people.
•Ability to analyze and interpret data.
•Ability to function independently and manage own time and work tasks.
•Ability to work as an effective team member.
•Ability to organize workflow.
•Ability to negotiate, persuade and establish direction.
•Ability to maintain office files and follow standard office procedures.
•Skilled job requiring high level of adaptability & interpersonal skills.
•Ability to interact with internal and external constituents.
CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP)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.
Required fields are indicated with an asterisk (*).
- * Do you possess a high school diploma or GED equivalent?
- * Do you have a Bachelors Degree OR equivalent training acquired via work experience or education?
- * Please indicate your years of previous job-related experience:
- Less than 1 year
- One to three years
- Three to five years
- Five to ten years
- More than ten years
- * Are you a Certified Clinical Research Associate (CCRA) or equivalent (SoCRA or ACRP)?
- * Why do you want to work for Loyola University Chicago?
(Open Ended Question)
- * How did you hear about this employment opportunity?
(Open Ended Question)
- Cover Letter/Letter of Application