In-House Clinical Research Associate II

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Execute site management responsibilities for clinical trials in accordance with GCPs, regulations, and SOPs

• Assist Clinical Trial Managers and field Clinical Research Associates

• Aid in the completion of site feasibility questionnaires and the collection of CDAs

• Oversee the shipment and receipt of study materials

• Revise and update site documentation for submission to the Trial Master File

• Contribute to the maintenance of the Investigator Site File, TMF reconciliation, and quality-control checklists

• Perform pre-study, initiation, interim, remote monitoring, and close-out visits under supervision

• Maintain active communication with clinical study sites

• Evaluate EDC case report forms for completion, logical consistency, and data-entry compliance

• Assist sites with resolving EDC and vendor queries

• Create portal and EDC reports and keep study trackers updated

• Prepare materials for field CRA visits and summarize action items, protocol deviations, queries, supplies, and training

• Facilitate changes in site staff, collection of essential documents, regulatory paperwork, training, and task delegation

• Manage access to vendor systems for site personnel

• Assist with prescreening, screening, and recruitment efforts

• Monitor subject eligibility reviews and provide support to the Medical Monitor

⛳️ Requirements

• Strong oral and written communication abilities

• Excellent planning, organizational, interpersonal, and time-management capabilities

• Capacity to work in a structured and methodical manner

• Fundamental understanding of clinical research principles and processes

• Knowledge of FDA and/or EU regulations, ICH Guidelines, and local regulatory standards

• Familiarity with standard operating procedures

• Basic proficiency in Microsoft Office

• Experience with IVRS and eCRF systems

• Completion of a two-year college curriculum or equivalent education/training along with one year of clinical research or related experience

• Alternatively, relevant education/training and at least two years of clinical research experience may be considered

• Fluency in the local languages of the countries under responsibility

• Proficient in both spoken and written English

🏝️ Benefits

• Diverse and inclusive work atmosphere

• Supportive and collaborative teams

• Accessible leadership

• Equal employment opportunities

• Outstanding employee experiences

• Opportunities for professional development and success