Regulatory and Start Up Specialist

IQVIA; A distancia; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A global healthcare company is seeking candidates for a home-based role focusing on Site Activation. This position requires Spanish language fluency and at least one year of clinical research experience within submissions. Responsibilities include serving as a single point of contact for investigative sites, ensuring compliance with regulations, preparing regulatory documents, and monitoring project timelines. The role is suitable for individuals looking to contribute to impactful clinical research projects.

Formación

• 1-year clinical research experience within submissions.
• Equivalent combination of education, training, and experience.

Responsabilidades

• Serve as Single Point of Contact for investigative sites and project teams.
• Ensure adherence to SOPs and project timelines.
• Prepare site regulatory documents and ensure accuracy.
• Review and follow up on site performance metrics.

Conocimientos

Spanish language fluency

Clinical research experience

Quality control skills

Educación

Bachelor's degree or equivalent

Descripción del empleo

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based role that requires Spanish language fluency.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

1-year clinical research experience within submissions. Equivalent combination of education, training and experience.