Apply on Employer Site

Waco Tribune-Herald · 1 week ago

Senior Regulatory Coordinator

Chicago, IL

Contract

Onsite

Mid, Senior Level

$30/hr - $33/hr

3+ years exp

Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence and commitment to community engagement. They are seeking a Senior Regulatory Coordinator to manage regulatory compliance for clinical trials, ensuring adherence to federal regulations and facilitating communication among study teams and regulatory bodies.

FitnessNewsPublishingSports

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

Qualification

Clinical Trials RegulatoryIRB submissionsFDA documentationMedical terminologyProject ManagementSOCRA certificationMicrosoft OfficeREDCapDatabase proficiency

Required

Bachelor's Degree

3 – 5 years of Clinical Trials Regulatory experience is required

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

Proficient in Microsoft Office suite

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