REGULATORY COORDINATOR
- Employer
- Loyola University Chicago
- Location
- Maywood-Health Sciences Campus
View more
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
Job Details
REGULATORY COORDINATOR
Position Number:8150118
Job Category:University Staff
Job Type:Full-Time
FLSA Status:Non-Exempt
Campus:Maywood-Health Sciences Campus
Department Name:ONCOLOGY INSTITUTE
Location Code:ONCOLOGY INSTITUTE (06310A)
Is this split and/or fully grant funded? :Yes
Duties and Responsibilities:-Communicates with the CCTO study teams and disease programs distributing new NCTN study activations, closures, termination, amendments and safety reports, etc.
-Processes IRB submissions to include but not limited to annual reviews and Adverse Event Reports.
-Communicates with NCI ,CTSU, COG and all NCTN Network Groups regarding protocol activations and overall protocol management.
-Tracks all IRB submissions completed by the Cancer Clinical Trials Office and prepare productivity reports.
-Maintains protocols and protocol documents on the CCTO website which includes data entry in Velos CTMS database.
-Conducts internal regulatory audits and prepare regulatory files for NCTN Network Group and COG audits as needed.
-Maintains Drug Safety list reports.
-Participates in the development of standardized processes within the CCTO as it relates to general regulatory compliance.
-Provides training for new staff with regard to clinical trial regulatory affairs.
-Orders and processes routine office supplies.
-Performs related duties as assigned.
Bachelor’s degree with three years of job related experience; or an equivalent combination of training and experience.
Qualifications:- Ability to follow verbal 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.
Research experience and SOCRA certification desirable.
Computer Skills:Proficiency with MS Office Suite, Internet and email applications. Strong verbal and written communication skills.
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:04/26/2021
Quick Link for Posting:Organization
Working at Loyola University Chicago
Loyola University Chicago, a private university founded in 1870 as St. Ignatius College, is the nation’s largest Jesuit, Catholic University and the only one located in Chicago. Shaped by our city and our Jesuit traditions, Loyola University Chicago offers students an educational environment unmatched for its diversity of thought and experience.
Loyola University Chicago comprises four campuses: Lake Shore (LSC), Water Tower (WTC), Health Sciences (HSC), and the John Felice Rome Center in Italy, and is home to eleven schools and colleges: Arrupe College, Quinlan School of Business, Marcella Niehoff School of Nursing, Stritch School of Medicine, College of Arts and Sciences, School of Communication, School of Continuing and Professional Studies, School of Education, School of Law, School of Social Work, and Graduate School. Loyola also features course locations in Beijing, China; Saigon-Ho Chi Minh City, Vietnam; Vernon Hills, Illinois (Cuneo Mansion and Gardens); and a Retreat and Ecology Campus in Woodstock, Illinois.
With three campuses spread throughout the greater Chicago area, students have access to hundreds of cultural institutions as well as thousands of internships and networking opportunities with the city's Fortune 500 companies. Study-abroad programs at our Rome and Beijing Centers provide engagement with the global community and economy.
While rigorous programs of research and study are one hallmark of a Jesuit education, we're not just preparing students for a career, we're preparing them for life. We challenge our students to learn broadly, to think critically, to serve generously, to lead with integrity, to respect diversity. We come from all faiths and ethnic and economic backgrounds, with a common purpose of building a better society.
Recognizing Loyola’s excellence in education, U.S.News and World Report has ranked Loyola consistently among the "top national universities" in its annual publications, and named the University a "best value" in its 2008 rankings.
Our faculty take a person-centered approach to education. They’re not just here to teach students what they know, they’re here to teach them to think critically and creatively and to reach for their own discoveries.
More facts about Loyola University Chicago:
- Total enrollment: 15,902
- 80+ undergraduate majors and 80+ minors
- 140+ graduate, professional, and graduate-level certificate programs
- More than 4,000 faculty and staff members
- 14:1 Undergraduate student/faculty ratio
- 150,000 alumni; 85,000 in Chicago
- One of only eight percent of all American colleges and universities to have a Phi Beta Kappa honor society chapter
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