Senior Site Start up Associate / Senior Clinical Research Associate (Medical)

TL;DR

Senior Site Start up Associate / Senior Clinical Research Associate (Medical): Coordinating site initiation and regulatory submissions for clinical trials with an accent on regulatory compliance and site management. Focus on executing EC/IRB applications, negotiating contracts and budgets, and performing high-quality clinical monitoring to ensure data integrity and patient safety.

Location: Argentina

Company

hirify.global is a clinical research organization helping biotech, medtech, and specialty pharma companies transform science into new medicines and diagnostics.

What you will do

• Prepare and submit Central and Local EC/IRB applications and RA submissions, including amendments and periodic notifications.
• Oversee essential document collection and review to ensure compliance with ICH/GCP guidelines and local regulations.
• Negotiate local investigator contracts and budgets using country templates.
• Conduct site identification and verify investigator eligibility for clinical trial protocols.
• Deliver quality monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
• Perform countrywide monitoring (remote or onsite) with a focus on data integrity and patient safety.

Requirements

• Undergraduate degree in a clinical, science, or health-related field.
• 3-5 years’ experience as a SSUA or in the submission of local clinical trial applications.
• At least 4+ years of independent monitoring experience.
• Proven experience in contract and budget negotiation.
• Broad experience with interventional IMP, non-interventional, medical device, GMO, and observational studies.
• Thorough knowledge of ICH GCP, EU Directives/Regulations, and local clinical monitoring procedures.

Culture & Benefits

• Focus on professional growth, providing skills and opportunities to excel.
• Work environment designed for flexibility and life balance.
• Collaborative culture where employee ideas influence the way the company works.
• Opportunity to contribute to medical innovations that save and improve patient lives.