公司简介:
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 partnership with our clients.
Website: ww***com[点击查看]
Email: hr@
Telephone: 021-68883271-807
招聘职位：
1. Clinical Research Associate （临床研究员）
Location:(Shanghai, Beijing)
职位描述：
- 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, pharmacy science or nursing;
- Self-motivated, interested in the clinical research work;
- Excellent interpersonal skills, negotiation skills and presentation skills;
- Good 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.
2. Clinical Research Coordinator（临床研究协调员）
Location:(Shanghai, Beijing)
职位描述：
Responsibility:
- Assist the study investigators in global oncology study with patient recruitment and retention, protocol compliance, regulatory documentation, case record form entry and Ethics Committee (EC) submissions.
Requirements:
- Bachelor or above Degree in Medicine or Nursing is a MUST;
- Familiar with hospital environment;
- Excellent communication skills with doctors and patients;
- Teamwork spirit;
- Can work under pressure;
- Doctor or nurse who has medical imaging experience and is interested in clinical research is preferred
3. Medical Coder（医学编码员）
Location:(Shanghai, Beijing)
职位描述：
- Perform coding of studies including query generation for ambiguous medical terms;
- Ensure coding consistency review under supervision of Senior Coding and Dictionary Specialist;
- Ensure coding reconciliation of SAE with Pharmacovigilance
- May have to participate in the definition of the project specific coding conventions in conjunction with Pharmacovigilance and clinical;
- Provide support to colleagues in D&C group as necessary (coders or dictionary managers).
Requirements:
- Paramedical professional with minimally a B.S. or B.A. in Life Sciences;
- Familiar with autocoding processes and tools e.g. dsNavigator, Clintrial Classify/Resolve or Oracle Clinical TMS;
- Competent in Microsoft Office applications (Word, Excel, Power Point, etc);
- Understanding of clinical development and ability to interact with clinical development teams (Clinical, Pharmacovigilance, statistics..);
- Proficiency with Microsoft Word, Excel, Power Point and other software packages;
- Experience with SQL/SQL Plus preferred;
- Experience with NCI Common Toxicity Criteria and ICD9-CM a plus.
4. Statistical Programmer（统计分析师）
Location:(Beijing)
职位描述：
Provide timely statistical and/or programming support for
- The study team for Clinical Study Report (CSR) deliverables according to Statistical Analysis Plans (SAPs), develop and execute validation plans;
- The implementation of data review plans;
- Regulatory submissions and ensure quality and appropriateness of submission deliverables;
- Processing data from clinical studies and developing useful tools, as applicable;
- Department functions on all programming matters according to the global project strategies.
Requirements:
- At least master degree in statistics, computer science, or relevant filed;
- Relevant clinical trial experience required;
- At least 2 year SAS programming experience in clinical development;
- Familiar with CDASH, CDISC;
- Effective English verbal and written communication skills in relating to colleagues and associates both inside and outside the organization;
- Ability to work effectively in a multi-cultural context as a good team member.
|
|
