Job expirat
Regulatory Affairs opportunity at a global CRO in Romania.
Core Responsibilities
-Preparation of submissions to the Competent Authority
-Preparation of submissions to Ethics Committees
-Preparation of essential documents
-Researches local requirements for documentation for regulatory and ethics approval submissions, and subsequent follow-up documentation.
-Provides updates of local processes and requirements to Regulatory for central repository.
-Acts as key liaison between Clinical Operations and Regulatory.
-Provides training in local regulations, requirements and essential document processes to local company’s employees, and to Clinical Regulatory Specialists in other locations.
-Maintains local essential document checklists.
-Assists with the development of the essential document plan (as part of the Monitoring Plan), essential documentation checklists and other study documentation, as per study specific requirements
-Obtains local document filing requirements, to assist Lead CRS with creation of appropriate document flow process
-Provides guidance and/or assists in the development of the subject information sheet/informed consent (SIS/IC) for country & site requirements
-Reviews and ensures SIS/IC for compliance with CFR, GCP and local requirements, as applicable
-Assists with preparation and submission of local submissions to the Competent Authority per Sponsor request and according to project requirements, in conjunction with Regulatory
-Acts as the local contact for the Competent Authority
-Responsible for the submission of regulatory documents to Ethics Committees on behalf of Sponsor and clinical sites
-Collaborates with local CRA and Lead CRS to address questions pertaining to essential documents
-Maintains working relationship with other local company’s personnel to ensure that essential documents of high quality are retrieved and maintained in a timely manner -Reviews study documentation received from sites; assesses accuracy, completeness and compliance with Sponsor requirements and regulatory guidelines.
-Provides regular local status updates to Lead CRS; updates appropriate study-tracking solutions with local essential document status
-Communicates any issues to Lead CRS and/or project team as appropriate
-Assists and reports to Lead CRS/Lead CRA/Project Leader/Regulatory Consultant as appropriate
-At conclusion of study, assists the Lead CRS with delivering to sponsor a complete and accurate study documentation portfolio as per sponsor request
-As Lead CRS, coordinates all local CRS activities and communicate to Lead CRA/PL
-As Lead CRS, may perform secondary quality review of local essential documents to ensure consistency across the study
Job Summary
A local expert on regulatory and ethics processes/documentation requirements for the start-up and conduct of clinical trials according to Good Clinical Practice and local regulations. A local contact for Competent Authorities, Ethics Committees (as applicable) and company’s personnel. Assumes a project role; coordinating the creation, submission, approval and quality review of local essential documents required for Phase I-IV studies, as per project assignment. May assume the role of Lead CRS on multinational projects, providing direction and guidance to the project team and coordinating all local CRS activities, as per project assignment.