Regulatory and Start Up Specialist

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will include clinical trial submissions, Informed Consent Form review, Essential Document collection, and supporting sites on IRB/EC submissions. Essential functions of the job include delivering site activation readiness, preparing Clinical Trial Application Forms, interacting with CA/EC, and providing regular updates to the Start Up Lead. The role requires maintaining project plans, developing study-specific start-up plans, partner with the assigned site CRA, and managing essential documents. The RSS will act as SME for critical path to Site Activation data points and participate/support the negotiation of study budgets. The role requires an updated knowledge of local clinical trial laws, regulations, and maintaining audit/inspection readiness. May support process improvement initiatives, training, and mentoring.