Job Title:
Regulatory Coordinator
Summary:
As a Regulatory Coordinator at Fortrea, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries. You will coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority. Your goal will be to ensure timely submission of study documentation, including country application forms and cover letters, and interact with Regulatory Authorities as needed.
Key Responsibilities:
* Maintain awareness of current regulatory standards and legislation in the assigned countries.
* Coordinate the preparation and submission of study documentation to EC/IRB/Third body/Regulatory Authorities.
* Liaise with internal and external vendors to generate Regulatory Authority submissions.
* Perform reviews of final submission documents.
* Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and within regulatory requirements.
* Prevent and escalate study issues appropriately and in a timely fashion.
In Country Specific Tasks:
* Serve as primary contact for investigative sites and ensure required documents are collected in a timely manner.
* Collect and track necessary documents, perform quality reviews, and compile final documents for effective site activation and maintenance.
* Ensure high-quality documents are filed and systems are updated on an ongoing basis.
* Participate in team meetings and provide accurate projections and timelines to study teams.
Clinical Trials Information System (CTIS) Tasks:
* Assist in uploading submission documentation to CTIS, interacting with and monitoring notifications and alerts to ensure milestones and events are met.
Requirements:
* University degree or certification in life science or related field, with 2 years' experience in clinical research, including knowledge of ICH guidelines and RA, IRB/IEC regulations.
* Fortrea may consider equivalent experience in lieu of educational requirements.
* High School Diploma or equivalent with a minimum of 2 years' work experience in clinical research, including knowledge of ICH guidelines and RA, IRB/IEC regulations, will also be considered.
Preferred Qualifications:
* Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budget negotiation process.
* Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
Physical Demands/Work Environment:
* General Office Environment.