- Clinical research jobs
- Regulatory & Start Up Specialist, FSP
Regulatory & Start Up Specialist, FSP
IQVIA Holdings Inc.
Primary Location: Buenos Aires, Argentina
Additonal Locations: Santiago, Chile,CHL
We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role!
What You´ll DoPerform 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.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
#LI-AA8
Job posted: 2023-11-10