Central Regualtory Coordinator

INNOVO RESEARCH INC•Champaign, IL

3d•$25 - $26•Remote

About The Position

We are seeking a highly organized and effective Central Regulatory Coordinator II to join our team remotely. As the Central Regulatory Coordinator II, you will be responsible for managing and maintaining regulatory documentation (electronic regulatory binders), serving as a site liaison, and supporting compliance with regulatory requirements. This position reports directly to the SVP of Partnerships and Strategy

Requirements

Bachelor’s degree in life sciences, nursing, or related field.
Minimum of 2 years of experience in regulatory affairs or clinical research industry.
In-depth knowledge of regulatory requirements for clinical trials, including FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) standards.
Strong organizational skills with the ability to manage multiple projects simultaneously and meet tight deadlines.
Proactive communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
Detail-oriented mindset with a focus on accuracy and quality.
Proficiency in Microsoft Office Suite and experience with clinical trial management systems (CTMS) preferred

Responsibilities

Lead the centralized regulatory function across all Innovo clinical research sites.
Develop and/or implement standardized regulatory processes, tools, and templates.
Manages electronic regulatory binders and associated documentation in accordance with SOPs and regulatory standards.
Serves as a site liaison to prepare for interim monitoring visits (IMVs), participate in SIVs, kick-off meetings, and conduct close out visits (COVs).
Ensure each study is audit-ready (ex. IMV preparation, SIV/COV preparation, QA check on eReg, etc.) and support sites as directed in preparation for inspections and monitoring.
Oversee and support the sites with study start-up collection, preparation, review, and submission of regulatory documents including 1572s, CVs, medical licenses, training logs, and financial disclosures
Oversee the drafting, customization, and submission of ICFs across all studies and sites.
Maintain version control and ensure sites are trained and using the most current IRB-approved versions.
Responsible for regulatory documentation management; manage and maintain regulatory documentation including Institutional Review Board (IRB) submissions and amendments. Includes the timely preparation, submission, and tracking of regulatory documents to the sponsor/CRO and IRB.
Assist in protocol-specific training to internal teams on protocol requirements, processes, and best practices.
Identify, report, and assess regulatory risks associated with protocol deviations, amendments, and adverse events, and collaborate with cross-functional teams to mitigate risk.
Track and maintain training documentation for the research team, as requested, to help ensure compliance with training requirements of Principal Investigators (PIs), Sub-Investigators (Sub-Is), and Clinical Research Coordinators (CRCs)/Research Assistants (RAs).
Ensure CVs, medical licenses (MLs), Good Clinical Practice (GCP) training, International Air Transport Association (IATA) training, and Occupational Safety and Health Administration (OSHA) training are up to date.
Performs all additional duties as assigned.