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Reg & Start Up Spec 2

hace 5 meses

Buenos Aires, Argentina IQVIA A tiempo completo

We are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role

**What You´ll Do**
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.
- 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, 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.

**What Will Help You Succeed**
- +2 years clinical research experience submitting clinical procedures to the MoH (ISP).
- Health Sciences degree
- +1 year experience handling the "FEFYM" and “CABA” portal when submitting clinical procedures
- Advanced command of English language.
- Desirable experience in imports/exports that correspond to activities subsequent to the authorization of a clinical protocol in the country.
- Desirable experience in contract negotiations with research sites.