Field Dd-Lwd Specialist: On-Site Drilling Expert

Zulay Kitchen; Quilmes; Remote; ARS 900,000 - 1,300,000; Full time

Job summary

Zulay Kitchen is seeking a Site Activation Specialist to manage country-level activation tasks and regulatory document preparation for Argentina. The role involves acting as the SPOC for sites and project teams, ensuring SOP adherence and timely delivery across activation activities.

You will coordinate with SAMs and management on timelines, conduct QA of documents, and provide local regulatory expertise during planning and execution. Fluency in English and strong communication are required.

Qualifications

• Bachelor's degree required.
• 2+ years of clinical research experience; CRA experience a plus.
• Experience in regulatory activities in Argentina, including ethics committees/ANMAT.

Responsibilities

• Serve as SPOC for investigative sites, SAM, PM team, and other departments.
• Perform startup and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems and tracking tools with project data.
• Provide feedback on site performance metrics and project timelines.
• Coordinate planning, timelines, and contingency measures as needed.
• Inform team of regulatory/contractual document completions.
• Oversee document approvals and releases aligned with timelines.
• Offer local expertise during project planning.

Skills

English proficiency

Communication

Organizational skills

Education

Bachelor's degree

Job description

Buenos Aires, Argentina
Full time
R
Site Activation Specialist
Full Home-based - Argentina
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.
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

• Bachelor´s degree
• 2+ years of clinical research experience, clinical trial assistant experience is a plus.
• Experience in clinical research regulatory activities in Argentina, including presentations to ethics committees and ANMAT (SSU and maintenance phases)
• Good command of English Language
• Excellent communication and interpersonal skills
• Excellent organization ad priorization skills