In-House Clinical Research Associate I/II – Spanish, English, Portuguese

This is a fully remote position, open to applicants in Argentina, +1 more country.

📋 Description

• Assist in site management tasks throughout the entire study lifecycle, encompassing feasibility assessments, study initiation, remote monitoring, and close-out procedures.

• Maintain consistent communication with designated sites and collaborate with Clinical Trial Managers and field CRAs.

• Evaluate site documentation for accuracy and completeness.

• Aid in the filing and reconciliation of the Trial Master File (TMF) and assist in maintaining Investigator Site Files (ISFs).

• Review electronic data capture (EDC) records and support sites in resolving data management and vendor inquiries.

• Prepare CRAs for site visits by tracking and communicating action items, protocol deviations, outstanding queries, study supplies, training, and other pending activities.

• Coordinate study materials, assist with site staff transitions and system access, and ensure training, qualifications, delegation, and regulatory documents are up to date.

• Support site prescreening, screening, recruitment, and tracking of Subject Eligibility Reviews.

• Maintain study trackers, extract information from study-specific portals and systems, and provide timely updates to Clinical Trial Managers and project teams.

• Act as a primary operational contact for clinical research activities when necessary.

⛳️ Requirements

• A four-year college degree with a major in medical, biological, physical, health, pharmacy, or another related science is preferred.

• Alternatively, a two-year college degree or equivalent education/training combined with at least one year of relevant clinical research experience may be accepted.

• Alternatively, other relevant education/training along with a minimum of two years of clinical research experience may be considered.

• Fundamental understanding of clinical research principles and processes.

• Knowledge of applicable FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures.

• Excellent written and verbal communication abilities.

• Strong planning, organizational, and time-management skills.

• Basic proficiency in Microsoft Office.

• Familiarity with IVRS and electronic CRF systems.

• Proficiency in spoken and written English, Spanish, and Portuguese.

• Fluency in the local languages of the countries under your supervision.

🏝️ Benefits

• A collaborative and inclusive work atmosphere.

• Opportunities for growth and learning.

• The chance to make a meaningful impact in clinical research that improves patients' lives.

• Remote work options available.