Job Details

A company is looking for a Start Up Specialist, FSP.Key Responsibilities:Maintain awareness of regulatory legislation and coordinate required documentation for submissions to EC/IRB/Third body/Regulatory AuthoritiesEnsure compliance with applicable laws and guidelines while managing start-up and maintenance activitiesServe as the primary contact for investigative sites, ensuring timely collection and quality review of necessary documentsRequired Qualifications:University/College degree (life science preferred) or relevant certification with 2 years of clinical research experienceHigh School Diploma or equivalent with a minimum of 2 years of clinical research experience may be consideredMinimum of 2 years of experience in clinical development or start-up/regulatory processesStrong working knowledge of ICH guidelines and RA, IRB/IEC regulationsExperience working with Canadian sites and strong negotiation skills with Canadian and US sites