Regulatory and Site Start Up Specialist
Regulatory and Site Start Up Specialist
> ROLE OVERVIEW
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. We have a strong focus on Oncology and Rare Disease. The Regulatory and Site Start Up Specialist is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation.
> CORE RESPONSIBILITIES
- Initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees
- Informed Consent Form review and adaptation
- Essential Document collection and quality review
> HARD REQUIREMENTS & SPECS
- Experience in regulatory and site start-up activities
- Ability to foresee and mitigate any risks
- Knowledge of international and local/national applicable regulations, company SOPs, and principles of ICH-GCP
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