Fortrea Start-up Specialist Job for BS/MS Lifescience candidates – Apply Now!
Fortrea is hiring a Start-up Specialist in Taipei! This full-time opportunity is ideal for experienced clinical research professionals who understand regulatory processes and start-up documentation. If you have at least 2 years of experience in clinical development and are passionate about compliance, timelines, and site activation, this role is for you. Apply now to be part of a world-class clinical research team!
Job Overview:
Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor.
- Locations: Taipei
- Time Type: Full time
- Posted on: Posted Today
- Job Requisition ID: 252676
Summary of Responsibilities:
- Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
- Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority.
- Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities.
- Liaise with internal and external vendors for submissions.
- Review final submission documents as applicable.
- Ensure all start-up and maintenance activities are on track and compliant.
- Prevent and escalate study issues appropriately.
- Perform other duties as assigned by management.
In Country Specific Tasks (Global):
- Serve as the primary contact for investigative sites and ensure timely collection of required documents.
- Perform document quality review and ensure timely, compliant site activation.
- Keep systems updated and audit-ready.
- Assist in Site Activation strategy and timeline projections.
- Customize and review patient informed consent forms for compliance.
- May support contract/budget negotiations.
- Identify and escalate risks to deliverables.
- Notify the Submissions Lead of out-of-scope hours.
Clinical Trials Information System (CTIS) Tasks (EU):
- Upload and monitor submission documentation.
- Ensure milestones and events are met within mandated timelines.
- Perform additional duties as assigned.
Qualifications (Minimum Required):
- University/College degree (life science preferred) or relevant allied health certification.
- Minimum of 2 years of work experience in clinical research.
- Strong knowledge of ICH guidelines and regulatory requirements.
Note: High School Diploma holders with 2+ years of clinical research experience will also be considered.
Experience (Minimum Required):
- 2+ years in clinical development or regulatory start-up.
- Familiarity with IRB/IEC guidelines, start-up documents, and budget/contract processes.
- Understanding of protocol requirements and ability to communicate them effectively.
Physical Demands/Work Environment:
General Office Environment.
Learn more about our EEO & Accommodations request here.
Keywords: Start-up Specialist, Clinical Research, Regulatory Submissions, Fortrea, Taipei Clinical Jobs, Clinical Trial Start-up Jobs, Fortrea Start-up Specialist Job
