Clinical Research Coordinator I
Loyola University Chicago
Chicago, IL
Full-time
Research
Posted on April 12, 2024
Position Details
Position Details
Job Title
CLINICAL RESEARCH COORDINATOR I
Position Number
8150814
Job Category
University Staff
Job Type
Full-Time
FLSA Status
Non-Exempt
Campus
Maywood-Health Sciences Campus
Department Name
CBCC Research
Location Code
CBCC RESEARCH (06310A)
Is this split and/or fully grant funded?
Yes
Duties 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.
Minimum Education and/or Work Experience
.
Qualifications
- 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.
Certificates/Credentials/Licenses
CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is desired
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 Responsibilities
No
Required operation of university owned vehicles
No
Does this position require direct animal or patient contact?
No
Physical Demands
None
Working Conditions
None
Open Date
01/11/2024
Close Date
Special Instructions to Applicants
Diversity and Inclusion Statement
Diversity, Equity, and Inclusion
As one of the nation's largest Jesuit, Catholic universities, Loyola University Chicago fosters a transformative cultural experience that honors diversity, equity, and inclusion. We are committed to not only recruiting, but also retaining a diverse, mission driven workforce and enabling a culture of inclusiveness in an environment that values service excellence, stewardship, personal well-being, and professional development for all of our employees. Loyola University Chicago supports its staff and faculty with a wide array of affordable, comprehensive and competitive benefits centered on health and wellness, financial security, equity, and work-life balance. We actively seek those who wish to join our faculty, staff, and students in a community of diverse opinions, perspectives, and backgrounds supporting our Jesuit mission and striving toward the same goal of being persons for and with others.
Quick Link for Posting
https://www.careers.luc.edu/postings/27265
Supplemental Questions
Required fields are indicated with an asterisk (*).
Required Documents
Position Details
Job Title
CLINICAL RESEARCH COORDINATOR I
Position Number
8150814
Job Category
University Staff
Job Type
Full-Time
FLSA Status
Non-Exempt
Campus
Maywood-Health Sciences Campus
Department Name
CBCC Research
Location Code
CBCC RESEARCH (06310A)
Is this split and/or fully grant funded?
Yes
Duties 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.
Minimum Education and/or Work Experience
.
Qualifications
- 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.
Certificates/Credentials/Licenses
CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is desired
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 Responsibilities
No
Required operation of university owned vehicles
No
Does this position require direct animal or patient contact?
No
Physical Demands
None
Working Conditions
None
Open Date
01/11/2024
Close Date
Special Instructions to Applicants
Diversity and Inclusion Statement
Diversity, Equity, and Inclusion
As one of the nation's largest Jesuit, Catholic universities, Loyola University Chicago fosters a transformative cultural experience that honors diversity, equity, and inclusion. We are committed to not only recruiting, but also retaining a diverse, mission driven workforce and enabling a culture of inclusiveness in an environment that values service excellence, stewardship, personal well-being, and professional development for all of our employees. Loyola University Chicago supports its staff and faculty with a wide array of affordable, comprehensive and competitive benefits centered on health and wellness, financial security, equity, and work-life balance. We actively seek those who wish to join our faculty, staff, and students in a community of diverse opinions, perspectives, and backgrounds supporting our Jesuit mission and striving toward the same goal of being persons for and with others.
Quick Link for Posting
https://www.careers.luc.edu/postings/27265
Supplemental Questions
Required fields are indicated with an asterisk (*).
- * Why do you want to work for Loyola University Chicago?
(Open Ended Question) - * How did you hear about this employment opportunity?
- Public Job Posting
- Internal Job Posting
- Agency Referral
- Advertisement/Publication
- Personal Referral
- Website
- Other
Required Documents
- Resume
- Cover Letter/Letter of Application