FSP CRA II

Main Responsibilities:
As a Clinical Trial Monitoring Professional at SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites. You will also be responsible for maintaining study files, conducting pre-study and initiation visits, and liaising with vendors. Additionally, you will be responsible for all aspects of site management as prescribed in the project plans.

General On-Site Monitoring Responsibilities:
You will ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. You will also ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Furthermore, you will ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

Key Skills and Qualifications:
A minimum of 1 (One) year of Clinical Monitoring experience is preferred. The ideal candidate will have a thorough knowledge of ICH Guidelines and understanding of local regulatory requirements. They will also have a basic understanding of the clinical trial process and be able to work independently with minimal supervision. Good planning, organization, and problem-solving abilities are essential. The candidate should also have good communication and interpersonal skills, as well as computer competency.

About SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch:
SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is an innovative pharmaceutical company that is committed to revolutionizing the development process. We are seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our collaborative workspace nurtures personal growth, enabling you to make a meaningful global impact.