Research Associate – ICRA

This is a fully remote position, open to applicants in Argentina, +2 more countries.

📋 Description

• Oversee site initiation activities from feasibility and qualification to site activation.

• Establish and nurture professional relationships with investigators and site personnel as the primary liaison for designated sites.

• Prepare, review, negotiate, and finalize regulatory and site documentation, including confidentiality agreements, informed consent forms, translations, and amendments.

• Coordinate submissions and approvals with Institutional Review Boards, Independent Ethics Committees, Ministries of Health, and Regulatory Authorities.

• Create and monitor site activation strategies, timelines, and regulatory plans to facilitate project milestones.

• Ensure precise and high-quality documentation in clinical trial management, electronic trial master file, and trial master file systems.

• Identify, address, or escalate issues and risks related to site activation, recruitment, compliance, training, and data quality.

• Assist sites with access to study systems, training needs, and readiness activities.

• Ensure that assigned sites remain prepared for audits and inspections throughout the study lifecycle.

• Adhere to Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel standard operating procedures.

• Collaborate across departments to meet project milestones and deliverables, effectively communicating progress, risks, and challenges.

⛳️ Requirements

• Extensive experience in clinical research and study start-up.

• Exceptional problem-solving, communication, presentation, and stakeholder management abilities.

• Capability to work independently, manage multiple priorities, and make informed decisions in uncertain scenarios.

• Experience in global, matrixed, and multicultural environments.

• Strong attention to detail and a commitment to maintaining quality standards.

• Dedication to meeting project timelines.

• In-depth knowledge of clinical trial management systems, electronic trial master file systems, trial master file processes, and Microsoft Office applications.

• Familiarity with International Council for Harmonization Good Clinical Practice guidelines, local regulatory requirements, sponsor needs, and clinical trial start-up processes.

• Proficient oral and written communication skills in English.

• Strong capabilities in communication, organization, presentation, stakeholder management, and problem-solving.

🏝️ Benefits

• Home-based position that offers the flexibility associated with remote work.

• Supportive line managers and a well-connected team.

• Opportunities to enhance expertise in global study start-up and regulatory operations.

• Flexibility and opportunities for professional growth.