Clinical Protocol Coordinator
CLINICAL PROTOCOL COORDINATORPosition Number:
University StaffJob Type:
Maywood-Health Sciences CampusDepartment Name:
ONCOLOGY INSTITUTELocation Code:
HEMATOLOGY - ONCOLOGY (06508A)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: 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 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. Preferred experience in Hematology and Bone Marrow Transplant
CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) preferredComputer 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.
NoRequired operation of university owned vehicles:
NoDoes this position require direct animal or patient contact? :
03/03/2021Quick Link for Posting: