other
Posted Mar 11FSP CTC(Shanghai)
at Fortrea
Shanghai, ChinaOn-site
Responsibilities
- Maintain awareness of current regulatory standards related to submissions.
- Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.
- Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.
- Perform a review of final submission documents as applicable.
- Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards Prevent and escalate study issues appropriately and in a timely fashion.
- Perform other duties as assigned by management depending upon country and situational
- Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
- Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol.
- Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
Requirements
- Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work
- experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations. Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements. In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work
- experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.
- experience in clinical development or start-up/ regulatory process.
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
- Demonstrated understanding of research protocol
- requirements and proven ability to communicate them/educate others about them. Physical Demands/Work Environment: General Office Environment. Learn more about our EEO & Accommodations request here .
Additional details
- This role is for upcoming future opportunities that may arise at Fortrea.
- Fortrea is excited to connect with talented individuals for future opportunities.
- If you meet the job requirements, we'll invite you for an interview.
- If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.
- 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.
- Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements.
- Serve as local expert in project start-up activities for a particular country or region.
- Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable. Summary of
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
- requirements with proper supervision [if applicable].