臨床試驗專員 (Clinical Research Associate, CRA)(工作地點:國際前10大藥廠)
- 台北市信義區
- 1年以上
- 大學
(派駐國際前10大藥廠CRA) As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. 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. •Minimum 1 year experience as CRA. •In lieu of the above requirement, -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. •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.