Senior Regulatory Coordinator

LRES Corporation; Chicago (IL); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Coordinator to ensure compliance with federal regulations and manage clinical trial documentation. In this pivotal role, you will work closely with investigators and study teams, overseeing IRB submissions and maintaining regulatory documents. The ideal candidate will have a Bachelor’s degree and 3-5 years of experience in clinical trials regulatory affairs, with a strong ability to communicate effectively and manage multiple priorities. This is an exciting opportunity to contribute to impactful research in a collaborative environment that values ethical leadership and community engagement.

Qualifications

• 3-5 years of Clinical Trials Regulatory experience is required.
• Bachelor’s Degree is mandatory, with a preference for a Master’s in Regulatory Affairs.

Responsibilities

• Maintain compliance with Federal regulations and manage IRB submissions.
• Communicate with Study Teams and manage regulatory documentation.

Skills

Effective Communication

Project Management

Knowledge of Medical Terminology

Ability to Work Independently

Team Collaboration

Education

Bachelor’s Degree

Master’s Degree in Regulatory Affairs

Tools

Microsoft Office Suite

REDCap

Docusign

Job description

Employment Opportunities Designed to Help Us Collaborate in Creation!

Senior Regulatory Coordinator

Position Details

Job Title: SR. REGULATORY COORDINATOR
Position Number: 8150786
Job Category: University Staff
Job Type: Full-Time
FLSA Status: 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

• Stays current with Federal regulations and can apply knowledge to work related activities.
• Has working knowledge of regulations pertaining to retention of records, protection of human subjects, IRB, FDA, and other regulations governing clinical research.
• Communicates with the CCTO Study Teams and Disease programs distributing new NCTN Study activations, closures, termination, amendments and safety reports, etc.
• Submits new Study projects to the local IRB, Central IRBs including- Cancer Trials Support Unit (CTSU), National Marrow Donor Program (NMDP) and Central Institutional Review Board (CIRB).
• Completes and tracks IRB submissions including amendments, serious adverse events, closures, and annual reviews for local and central IRBs.
• Continually communicates with CTSU/NMPD/CIRB Coordinators to ensure all amendments are submitted within a timely manner to central IRB and the local IRB.
• Completes Principal Investigator worksheets in the CIRB manager IRB portal annually or as needed in order for PIs to maintain their eligibility to implement protocols within Loyola.
• Assists investigators in submitting emergency use Drug Applications as necessary and submits documents to FDA for annual review/as needed.
• Works closely with the Study Staff to schedule site initiation visits, monitoring visits, and close out visits.
• Works with the Contract Research Organizations and monitors for Study related management expectations and ensure regulatory compliance.
• Communicates with the local IRB to ensure all boilerplate templates for central IRBs align with regulations and local IRB standards.
• Maintains regulatory documents (including 1572s, Delegation of Authority logs, Financial Disclosure Forms, Consent Forms, and trainings) for pharmaceutical/CIRB and/or cooperative group protocols and ensures the Study Team and Investigators have completed the required training.
• Trains/assists new/seasoned Staff on regulatory process including CITI training, Study start-up, IRB submissions, maintaining a Study, and ensuring all essential documents are correct to submit to monitor/sponsor.
• Assists Staff in archiving Study files and ensures all Staff have appropriate box # to archive Studies, assists with boxing any regulatory files or patients charts in appropriate boxes, maintains a catalog of all Studies archive, and ensures all files are kept in a secure place.
• Coordinates regulatory agenda with regulatory coordinators/Leads weekly regulatory meetings.
• Meets with Principal Investigators to review all active, closed, and upcoming Studies and attends Research meetings with the multidisciplinary Teams.
• Coordinates meetings with the Study teams (Research Nurses and CRCs) weekly to review regulatory status of Studies.
• Assists investigators with CITI training and renewing their Cancer Therapy Evaluation Program (CTEP) number for the NCI Clinical Trials in the Registration and Credential Repository (RCR).
• Participates in internal/external audits to ensure regulatory compliance and implement corrective and preventive action plans as needed.
• Maintains CCCTO website with protocol, consents, and accurate status of (closed, temp closed, or pending).
• Maintains master tracker with other regulatory coordinators for Study statuses.
• Utilizes Docusign for Study needs as appropriate.
• Performs other duties as assigned.

Minimum Education and/or Work Experience

Required

• Bachelor’s Degree
• 3 – 5 years of Clinical Trials Regulatory experience is required.

Preferred

• Master’s Degree in Regulatory Affairs.
• Experience in working with the Oncology population.

Qualifications

• Ability to communicate effectively. Excellent written and verbal communication skills.
• Ability to maintain high standards of accuracy and consistency.
• Ability to function independently and manage assignments from multiple Stakeholders.
• Utilize Project Management skills to organize workflow, manage and shift priorities as needed, and complete work in a timely manner. Some work may be required to be completed under strict deadlines.
• Ability to work as an effective team member.
• Ability to facilitate work of others.
• Knowledge of medical terminology.

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?

No

Physical Demands

Repetitive Motions

Working Conditions

Irregular Hours

Open Date

03/07/2025

Close Date

Not specified

Position Salary

Maximum Salary or Hourly Rate: $33.00/hr
Minimum Salary or Hourly Rate: $30.00/hr

Special Instructions to Applicants

About Loyola University Chicago

Founded in 1870, Loyola University Chicago is one of the nation’s largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact.

With 15 schools, colleges, and institutes —including Business, Law, Medicine, Nursing, and Health Sciences—Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation’s top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country’s most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world.

Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. To view our benefits in detail, click here.

Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University’s Nondiscrimination Policy.

Supplemental Questions

Required fields are indicated with an asterisk (*).

• * Do you possess a Bachelor’s Degree and 3 - 5 years of Clinical Trials Regulatory experience?
  • Yes
  • No
• * Do you possess a Master’s Degree in Regulatory Affairs and experience in working with the Oncology population?
  • Yes
  • No
• * Please describe your experience with Clinical Research.

  (Open Ended Question)

• * 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

Applicant Documents

Required Documents

• Resume
• Cover Letter/Letter of Application

Optional Documents

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