Clinical Research Regulatory Specialist

3 hours ago

Chicago, Illinois, United States Insight Hospital and Medical Center Full time
Job Summary:

We are seeking a highly skilled Clinical Research Regulatory Specialist to join our team at Insight Hospital and Medical Center in Chicago, IL. As a key member of our research team, you will be responsible for ensuring the compliance of our clinical trials with regulatory requirements and industry standards.

Key Responsibilities:
  • Oversee the submission of IRB applications to governing agencies and provide foundational information for more complex regulatory work.
  • Prepare and maintain regulatory files for clinical research studies, reviewing them for completeness and accuracy.
  • Assist with start-up and site activation activities, adhering to applicable regulations, SOPs, and work instructions.
  • Distribute completed documents to associated sites and internal project team members.
  • Ensure the accurate completion and maintenance of internal systems, databases, and tracking tools to reflect project-specific information.
  • Assist staff and physicians with clerical duties and maintain overall organization while following regulations according to standards of Good Clinical Practice, HIPAA, and OSHA.
  • Responsible for compliance regarding regulatory procedures, including study preparation and maintenance, which includes interim reviews and study closure reports, SAE reporting and tracking, memo to file reports, maintenance of regulatory, correspondences, and visit binders, and completion of study closure files.
  • Review, track, and follow up on the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in accordance with project timelines.
  • Maintain good communication and follow-through when working with IRBs, tracking the regulatory process to ensure timely completion of regulatory approvals, changes, and reporting.
  • Maintain good communication and follow-through when working with sponsors and/or CROs throughout the conduct of the clinical trial.
  • Upkeep record archiving and destruction records, adhering to regulatory requirements.
  • Assist in the final close-out storage of clinical trial records.
  • Participate in educational training seminars on all topics of clinical research.
  • Maintain updated CVs and GCPs.
  • Prepare for monitoring visits and assist during the visits with regulatory issues.
  • Support processes and monitor practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies, procedures, and regulations.
  • Responsible for study completion processes, including but not limited to data lock, study closeout, reporting, and archiving of study files, ensuring completeness and continuity of all study data; performing day-to-day checks of clinical/translational data that has been entered on the case report forms (paper or electronic), source sheets, or in reports and assuring archival of appropriate/required documentation.
  • Assist research staff in developing, maintaining, and updating all internal and external protocols, data collection sheets, source sheets, and databases for use in gathering and compiling information specific to each research process.
  • Applied knowledge of the safety reporting requirements for the study protocol, FDA, and other regulatory bodies.
  • Monitor, detect, and report adverse events meeting requirements of regulatory bodies in a timely manner.
  • Complete and maintain regulatory documents for all study personnel, including curriculum vitae, license, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.
  • Compile and maintain eRegulatory Binders completed submission applications, along with other required documentation; prepare protocol-specific forms for submission to various review committees, including internal scientific review boards, the IRB, and sponsoring entities.
  • Complete protocol renewal applications, amendment applications, and maintain record of all adverse event reports.
  • Attend research team meetings to report on regulatory issues.
  • Other duties as assigned.

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