Study Start-Up Specialist: Site Activation & Compliance

Rho; United States; Presencial; USD 55.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical & vision insurance

401(k) and financial planning

Paid time off & holidays

Parental leave & bereavement leave

Descripción de la vacante

Rho seeks a Study Start-Up Associate to coordinate start-up activities across the project lifecycle, ensuring timely and high-quality delivery. You will work with the multidisciplinary team and Sponsors to plan site activation, regulatory submissions, and essential documents.

Requirements include a Bachelor's degree and at least 1 year in clinical research, with knowledge of ICH GCP and TMF processes. A supportive, stable environment awaits with opportunities for growth.

Formación

• Bachelor's Degree and at least 1 year of clinical research experience (CRO preferred).
• Familiarity with ICH GCP guidelines and regulatory submissions.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and meet deadlines.

Responsabilidades

• Participates in start-up through site activation, delivering timely, professional service.
• Collaborates with Feasibility, CTL, SSUL, Sponsor and site staff to collect and track feasibility responses.
• Supports Regulatory/IRB submissions and approvals at country and regional levels; maintains documentation in trackers and TMF.

Conocimientos

Project coordination

Regulatory & IRB submissions

Documentation management

Stakeholder communication

Team collaboration

Educación

Bachelor's Degree in clinical research or related field

Herramientas

TMF systems

Regulatory platforms

Descripción del empleo

Rho seeks a Study Start-Up Associate to coordinate start-up activities across the project lifecycle, ensuring timely and high-quality delivery. You will work with the multidisciplinary team and Sponsors to plan site activation, regulatory submissions, and essential documents.

Requirements include a Bachelor's degree and at least 1 year in clinical research, with knowledge of ICH GCP and TMF processes. A supportive, stable environment awaits with opportunities for growth.