Regulatory Coordinator - Maywood, United States - Loyola University Chicago

Loyola University Chicago

Verified Company

Maywood, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Position Details:

Position Details

Job Title

REGULATORY COORDINATOR
Position Number

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 indepth 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 jobrelated experience
Preferred: 12 years of previous jobrelated 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 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 wellbeing, 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 worklife balan