南京招聘

- Ensure sponsor and investigator obligations are being met and are in compliance with SFDA and ICH-GCP;
- Perform pre-study visits in order to select qualified sites;
- Perform site initiation visits;
- Perform regular interim site visits to review data and ensure accuracy of data collected;
- Conduct close-out visits to terminate the study at a certain investigative site;
- Perform source document verification;
- Oversee drug accountability at investigative sites;
- Retrieve Case Report Form (CRF) and perform query resolution in a timely manner;
- Support the investigators in study logistics;
- Ensure Serious Adverse Event (SAE) reporting according to project specification;
- Serve as key contact for the investigator;
- Document investigator contact report in a timely manner, including telephone and in-person visits;
- Document and perform follow-up of study status and site enrollment status;
- Document other study interactions such as interactions with the project team.

Requirements:
- Bachelor or above Degree in Medicine or Pharmacy is a MUST;
- More than 1 year clinical monitoring experience in global oncology studies in line with SFDA/ICH GCP;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Excellent communication skills with fluent verbal and written English and Chinese;
- Willing to work at sites and can travel frequently;
- Teamwork spirit;
- Can work under pressure.

Chelsea Clinical Research is a Shanghai-based Contract Research Organization (CRO) which provides a comprehensive range of clinical trial services to international pharmaceutical companies, biotechnology companies and research institutions in China.

Our mission is to deliver service excellence and timely, quality results for our clients. As a professional drug development organization, we believe in the value of building trusted parternership with our clients.