at Loyola University Of Chicago in Maywood, Illinois, United States
Job Description
Position Details
Position Details
Job Title
REGULATORY COORDINATOR
Position Number
8150786
Job Category
University Staff
Job Type
Full-Time
FLSA Status
Non-Exempt
Campus
Maywood-Health Sciences Campus
Department Name
CBCC Research
Location Code
HEMATOLOGY - ONCOLOGY (06508A)
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.
* Submits Drug Safety list reports to the IRB.
* 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.
* Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
* Serve as primary contact with sponsors, and regulatory agencies.
* Participate in monitor visits and regulatory audits.
* Establish and maintain research project's regulatory files
* Ongoing communication with the local IRB, federal organizations, affiliate institutions and pharmaceutical study sponsors.
* Participates in Cooperative Group Audits, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.
* Performs related 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
* Bachelor of Science or equivalent degree required; multiple years of clinical trial regulatory experience may be considered in combination with education in lieu of bachelor's degree.
* Clinical Trials Regulatory experience is preferred.
* Experience in working with clinical trials and/or oncology population preferred.
* Knowledge of medical terminology.
* Ability to communicate effectively. Excellent written and verbal communication skills.
* Ability to function independently and manage assignments.
* Ability to maintain accuracy and consistency.
* Ability to organize workflow.
* Ability to finish tasks in a timely manner.
* Ability to work as an effective team member.
* Ability to facilitate work of others.
* Must have project management skills.
* Computer skills necessary for working with databases and electronic data submission. Familiarity with web-based platforms: accessing information, obtaining necessary documents, access information regarding study groups and federal rules/regulations.
* SOCRA certification desirable
Certificates/Credentials/Licenses
SOCRA certification is desirable
Computer Skills
Proficient in Microsoft Office suite.
REDcap proficiency preferred
Computer skills necessary for working with databases and electronic data submission. Familiarity with web-based platforms: accessing information, obtaining necessary documents, access information regarding study groups and federal rules/regulations.
Supervisory Responsibilities
No
Required operation of university owned vehicles
No
Does this position require direct animal or patient contact?
Physical Demands
Repetitive Motions
Working Conditions
Irregular Hours
Open Date
05/16/2024
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... For full info follow application link.
Loyola University Chicago is an Equal Opportunity / Affirmative Action employer with a strong commitment to hiring for our mission and diversifying our faculty and staff. All qualified applicants will receive consideration for employment without regard to race, color, religion (except where religion is a bona fide occupational qualification for the job), national origin, sex, age, disability, marital status, sexual orientation, gender identity, protected veteran status or any other factor protected by law.
Loyola University Chicago is an Equal Opportunity Employer.
