南京招聘

职位描述：
Responsibilities:
Independent and proactive coordination of all the necessary activities required to set up and monitor a study , including but not limited to the following :
Identify investigators. Help when requested , in preparation of regulatory submissions .
Design of patient information sheets and consent forms .
Ensure timely submission of protocol/consent documents for ethics/IRB approval.
Pre study/placement and initiation visits.
Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate Maintain all files and documentation pertaining to studies .
Motivate investigators in order to achieve recruitment targets.
Complete accurate study status reports.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Keep the Project Manager regularly informed.
Process case record forms to the required quality standards and timelines.
Deal with sponsor generated queries in a timely manner.
Ensure the satisfactory close-out of investigator sites.
Participate, if requested, in the preparation of and review of study documentation , e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
Participate in feasibility studies for new proposals as required.
Ensure correct archiving of files on completion of a study.
Maintain patient and sponsor confidentiality .
Assume additional responsibilities as directed by the Project Manager. - lnvestigational Products (IPs) stored and managed by the site.

Requirements:
Tertiary qualification in Science or related field
MUST have at least 2 years monitoring experience
Strong communication and relationship building skills
Good multitasking, time management and prioritization skills
Proactive approach and ability to work autonomously as well as part of a team
Demonstrate professionalism, commitment and passion

Please feel free to reach out to ashley.li@iconplc.com for more details or referrals. 举报 分享

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.