Regulatory Coordinator

Job Summary

With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.

Essential Responsibilities and Duties

• Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including submission documents/approvals, protocol amendments with respective signature pages, informed consent documents, FDA form 1572, lab normal result documents, financial disclosure forms, delegation of authority logs, licenses, reports, and logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)
• Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials.
• Serve as a liaison between the IRB, site, and investigator.
• Obtain necessary signatures from investigators and staff.
• Maintains and tracks current staff credentials (i.e., CV, certifications, etc.)
• Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams.
• Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager.
• Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study.
• Submits applicable subject facing documents for translations.
• Maintains current Clinical Conductor Regulatory information.
• Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE's), protocol deviations and other required reports.
• Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents.
• Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary.
• Assists with regulatory inspections and sponsor audits as necessary.
• Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned.

Education/Experience/Skills

• Must be a high school graduate or have GED equivalency.
• 0-2 years of experience in clinical research regulatory affairs.
• Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner.
• Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
• Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
• Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.
• Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.
• Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals.
• A critical thinker with strong attention to detail and superb problem-solving abilities.
• Must be able to effectively communicate verbally and in writing.

Working Conditions

• Indoor, Office environment.
• Essential physical requirements include sitting, typing, standing, and walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.
• Ability to work overtime, weekends, and/or holidays as needed.
• Ability to travel as needed.
• Remote work arrangement depending on location.