招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
As a Clinical research specialist, you will be responsible for making sure that the applicable regulations, proper standard and relevant Medtronic SOPs of Clinical Evaluations are being met for all CTC designed products.
You may also be responsible for writing clinical study protocol and study reports, as well as other ad-hoc medical writing tasks with the supervision of Clinical Affairs Manager.
Depending on the level of experience and training received, you may also assist, conduct or lead clinical project management activities.
? Overall responsibility for clinical evaluations for the purpose of CE marking and CFDA registration and ad-hoc requests including additional clinical evidence for 510k clearance.
? Responsible for overall CER planning activities including checking existing evidence to minimize burden and leverage global resource
? Lead clinical evaluation kick-off meetings/discussions with project teams including functions such as technical, medical, quality and regulatory
? Perform the writing of CERs in-house or supervise writers from vendor company
? Responsible for providing background trainings to vendor on Medtronic SOPs, devices backgrounds, indications etc.
? Responsible for overall literature review strategy including defining the scope, key words, inclusion and exclusion criteria;
? Serve as liaison between vendor, R&D, IRC or other relevant Medtronic function team , responsible for tracking project progress and making sure input documents are obtained and uploaded timely
? Provide guidance to vendor writer on applying the CER template, ensure overall structure, and level of details are appropriate for the specific purpose of the clinical evaluation
? May serve as Subject Matter Expert of CFDA CER to global Clinical Affairs due to vicinity to local RA team and CFDA reviewers
? Depending on project needs and under supervision of Clinical Affairs Manager, take on additional Clinical Affair roles including writing of Clinical Investigation Protocol, and relevant report.
? Participate in literature search, medical writing skills and software trainings;
? Participate in clinical trial related trainings as well as project management trainings as needed
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