臨床試驗專員 II (Clinical Research Associate II, CRA II)(派駐國際前10大藥廠CRA)

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. Our Flexible Solutions Clinical Research Associates are based at our pharmaceutical client sites and manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include: •Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation •Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned •Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned •Site management as prescribed in the project plans •Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs •Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management •May support in organization of meetings and other tasks as instructed by supervisor. Requirements: •B.A./B.S. (Life Science preferred) or equivalent healthcare experience. -CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered. -SCRA: candidates with 4 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered. •Global clinical trial experience is needed. •Oncology study experience is needed. •Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements. •Basic understanding of the clinical trial process. •Fluent in local language and English. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.