Regulatory & Site Start-Up Specialist | Global Trials

Precision for Medicine; United States; Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to lead regulatory submissions, site activation and essential document management for clinical trials. The role involves collaboration with CA/EC, IRB submissions, and start-up teams to ensure compliant and on-time study activation.

You will review informed consent materials, coordinate translations, and support site contracts while maintaining TMF readiness and regulatory compliance across countries.

Qualifikationen

• Bachelor's degree in life sciences or life sciences related field or RN.
• 1 year+ experience as Regulatory or Site Start-Up specialist in CRO/pharma industry or equivalent.
• Fluency in English; local language knowledge for country may be required.

Aufgaben

• Ensure timely and quality site activation readiness for assigned country/sites.
• Prepare Clinical Trial Application forms and submission dossiers for CA, EC, and local bodies.
• Interact with CA/EC and provide responses as needed.
• Provide regular updates on submissions to Start Up Lead, Regulatory Lead and Project Manager.
• Maintain project plans, trackers and regulatory intelligence tools.
• Support development of start-up plans, IMP release requirements and document criteria.

Kenntnisse

Regulatory submissions

Site start-up

Budget negotiation

Documentation

Communication skills

Ausbildung

Bachelor's degree in life sciences or related field

Jobbeschreibung

Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to lead regulatory submissions, site activation and essential document management for clinical trials. The role involves collaboration with CA/EC, IRB submissions, and start-up teams to ensure compliant and on-time study activation.

You will review informed consent materials, coordinate translations, and support site contracts while maintaining TMF readiness and regulatory compliance across countries.