[Hiring] In-House Clinical Research Associate I / II @Worldwide Clinical Trials

Role Description

Help keep clinical studies moving forward by supporting effective site management throughout the study lifecycle. In this role, you’ll work closely with Clinical Trial Managers, field Clinical Research Associates, study sites, and cross-functional project teams to help deliver site activities accurately and on schedule.

You’ll have broad involvement across site management, from study start-up and essential documentation through remote monitoring, data review, recruitment support, and study close-out. Your work will help sites stay prepared, informed, and aligned with Good Clinical Practice (GCP), applicable regulations, and study requirements.

This is a remote role open to candidates based in Argentina or Brazil. You will collaborate with global teams across multiple time zones.

What You'll Do

• Support site management activities throughout the study lifecycle, including feasibility, study initiation, interim and remote monitoring, and close-out activities under appropriate guidance.
• Maintain regular communication with assigned sites and partner with Clinical Trial Managers and field CRAs to keep study activities and deliverables on track.
• Review site documentation for quality and completeness, support Trial Master File (TMF) filing and reconciliation, and help maintain Investigator Site Files (ISFs).
• Review electronic data capture (EDC) records for completion, logic, and compliance, and assist sites with resolving data management and vendor queries.
• Prepare CRAs for site visits by tracking and communicating action items, protocol deviations, outstanding queries, study supplies, training, and other open activities.
• Coordinate study materials, support site staff changes and system access, and help ensure required training, qualifications, delegation, and regulatory documentation remain current.
• Support site prescreening, screening, recruitment, and Subject Eligibility Review tracking, as applicable to the study.
• Maintain study trackers, pull information from study-specific portals and systems, and provide timely updates to Clinical Trial Managers and project teams.
• Serve as a key operational contact for clinical research activities when appropriate, helping sites and study teams address issues and maintain progress.

Qualifications

• A four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science is preferred; alternatively, a two-year college curriculum or equivalent education/training plus at least one year of relevant clinical research experience, or other relevant education/training plus at least two years of clinical research experience, may be considered.
• A basic understanding of clinical research principles and processes, with knowledge of applicable FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures.
• Strong written and verbal communication skills, with the interpersonal skills to work effectively with sites and cross-functional study teams.
• Good planning, organization, and time-management skills, with a methodical approach to managing multiple activities.
• Basic knowledge of Microsoft Office and familiarity with IVRS and electronic CRF systems.
• Proficiency in spoken and written English, Spanish, and Portuguese, along with fluency in the local languages of the countries under your responsibility.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers , or connect with us on LinkedIn .