南京招聘

1.Provide the inputs for site selections, assist with Clinical Study Lead(CSL) /CRA Lead in site selection.

2.Assist with CSL /CRA Lead in site preparation procedure , including but not limited supplies preparation in sites by collaborating with QIAGEN other teams. Ensuring sufficient supply of study materials to each site, and all materials are in good management and follow GCP.

3.Responsible for sites EC submission, contracts conclusion, authority submission.

4.Conducting SIV, assist with CSL/CRA Lead to align sites and QIAGEN engineers to execute site training .

5.Performs on-site monitoring visits, including but not limited to ICF/CRF/AE/materials records/source data and records, ensuring the studies are complied with study protocol, GCP, QIAGEN SOP and appropriate regulations. Ensure data accuracy, integrity, authenticity. Finding and fixing issues in sites.

6.Write IMV report, raise up issues timely to CSL /CRA Lead, follow the study progress in sites and attend the regular clinical trial meetings .

7.Manage the Investigational Site File(ISF), ensure study procedures are recorded as the requirements of protocol and appropriate requirements of regulations, files and binders are properly maintained and archived. Cooperate with CTA to manage the Investigational Master File (IMF).

8.Performs source documents verifications, including but not limited to ICF/CRF/source records/ subjects source data. Follow the queries from DM and query resolution.

9.Conduct SOV, ensure sites can be closed on time.

10.Coordinate with CRC, DM, investigators, make good relationships between parties.

11.Other tasks assigned by CSL/ CRA Lead.

Hiring requirement/preference:

1.At least 2 years clinical trial experiences, IVD/MD experiences preferred , drug study experience also applicable

2.Bachelor degree or above major in medicine/pharmaceutical/biology or related. Molecular biology background, clinical laboratory or hospital related background preferred.

3.Solid knowledge in GCP.

4.Willingness of travel.

5.Good communication skill ,teamwork spirit and cooperation skills.

6.Proficiency in computer skills.

QIAGEN is the leading provider of sample and assay technologies. Sample technologies are used to isolate DNA, RNA and proteins from any biological sample. Assay technologies are then used to make specific target biomolecules, such as the DNA of a specific virus, visible for subsequent analysis.
We have developed more than 500 consumable products and automated solutions. We are the market leader in academic research markets, to leading pharmaceutical and biotechnology companies, to molecular diagnostics laboratories as well as applied testing markets such as forensics, animal or food testing, and pharmaceutical process control.
QIAGEN employs more than 3,900 people in over 35 locations worldwide.

QIAGEN公司在全球35个国家，有着超过3900名员工和一支国际化的管理队伍。行业领先的技术使我们在未来能够持续成长和保持领先地位。
我们致力于全球生物技术市场。我们有着全球网络，代理商服务国家超过42个。同客户的紧密联系使得我们能够不断保持处于技术前沿，不断满足市场需求，不断完善我们产品发展系统。
从1986年以来，我们已经完善和上市了许多科研产品和工业的产品，应用于核酸纯化技术等方面，如：生命科学研究，基因组研究，基因药物发现，核酸分子诊断，基因疫苗和基因治疗市场等。核酸纯化市场的快速发展促使我们不断完善核酸纯化技术。