Responsibilities:
l Provide high quality assistance to support clinical trials according to applicable regulatory requirements and SOPs within timelines.
l Act as CRC (Clinical Research Coordinator) during the operation phase of clinical trial. Accountable for the timely and accurate entry of study information on a variety of databases and systems.
l Perform various job functions including but not limited to the following: tracking study specific documents, i.e. regulatory documents, enrollment and site activation, sample tracking, trial master folder maintenance, etc.
l Contribute to the development of study specific tools.
l Prepare, ship and manage inventory of study related supplies.
l Assist in preparing materials for investigator and team meetings, study manuals etc.
l Other duties and assignments as requested for the overall performance of the clinical team.
Qualifications:
l Bachelor degree in a relevant scientific discipline. Biochemistry and human/animal physiology are mandatory. Postgraduate education is a plus.
l Ability to prioritize multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures in a fast-paced environment
l Possess a general understanding of clinical trial and/or scientific research process.
l Strong attention to detail, and meticulous follow-through.
l CET-4 is minimum and CET-6 is preferable.
l Proficiency using Microsoft Word, PowerPoint, and Excel.
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