Clinical Trials Liaison Officer (CTLO)
The Clinical Trials Liaison Officer is the primary point of contact among KELUN, investigators and the sites, and provides professional advice and support related to regulation, management and conduct of clinical research in China. He or she is experienced in site monitoring and leads the investigator and site selection.
· Provide professional advice and support regarding the regulations, management, and conduct of clinical research in China.
· Assist in the preparation and submission of documentation (i.e. protocol, CRF and ICF) to ethics and competent authorities for companies, organizations, or individuals that do not have such services available locally.
· Be experienced in site monitoring and carry out site monitoring services.
· Be the primary point of contact among KELUN, investigators and the sites to implement the feasibility processing system of KELUN.
· Lead investigator candidates and site selection, gather the clinical operational information containing the recruitment tracking, study/trial development, progress monitoring and reporting.
· Take charge of the clinical trial management, including signposting services of specific study requirements such as IMP management, pharmacovigilance, data management, etc.
· Provide input to clinical development.
· Carry out any other duties that arise during the ambit of the post.
· Bachelor’s degree or higher in clinical or life sciences relevant training.
· A minimum of 5 years experience in biological medicine and the pharmaceutical industry.
· Solid understanding of medical health services and academic research in China.
· Familiar with Chinese and international regulations involving clinical trials.
· Excellent project management and organizational skills. Ability to deliver effective presentations, facilitate group discussions, communicate and interact with a diverse group of individuals.
· Proven ability to use IT tools.
· Fluency in Mandarin is preferred.