Clinical Start-Up Specialist
Behavioral Health Market Context
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Job Description
ely collection and quality review of necessary documents
Required Qualifications :
University / College degree (life science preferred) or relevant certification with 2 years of clinical research experience
High School Diploma or equivalent with a minimum of 2 years of clinical research experience may be considered
Minimum of 2 years of experience in clinical development or start-up / regulatory processes
Strong working knowledge of ICH guidelines and RA, IRB / IEC regulations
Experience working with Canadian sites and strong negotiation skills with Canadian and US sites
Required Qualifications :
University / College degree (life science preferred) or relevant certification with 2 years of clinical research experience
High School Diploma or equivalent with a minimum of 2 years of clinical research experience may be considered
Minimum of 2 years of experience in clinical development or start-up / regulatory processes
Strong working knowledge of ICH guidelines and RA, IRB / IEC regulations
Experience working with Canadian sites and strong negotiation skills with Canadian and US sites
Qualifications
- •High School Diploma or equivalent with a minimum of 2 years of clinical research experience may be considered
- •Minimum of 2 years of experience in clinical development or start-up / regulatory processes
- •Strong working knowledge of ICH guidelines and RA, IRB / IEC regulations
- •Experience working with Canadian sites and strong negotiation skills with Canadian and US sites
Benefits
Responsibilities
- •Maintain awareness of regulatory legislation and coordinate required documentation for submissions to EC / IRB / Third body / Regulatory Authorities
- •Ensure compliance with applicable laws and guidelines while managing start-up and maintenance activities
- •Serve as the primary contact for investigative sites, ensuring timely collection and quality review of necessary documents
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