FSP CRA I or II - Pu Dong Xin Qu, 中国 - Fortrea

描述

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.

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.

Responsibilities include:

Study startup which include site selection, recruitment of potential investigators

Negotiate study budgets

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:

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research 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

Workable English is a MUST

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.