Research Associate, ICRA

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

📋 Description

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

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

• Draft, review, negotiate, and finalize regulatory and site documents, which include confidentiality disclosure agreements, informed consent forms, translations, and amendments.

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

• Create and monitor strategies, timelines, and regulatory plans for site activation.

• Ensure the maintenance of precise, high-quality documentation within 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 requirements, and readiness activities.

• Guarantee that assigned sites are audit-ready and inspection-ready throughout the entirety of the study lifecycle.

• Uphold compliance with Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel standard operating procedures.

• Collaborate across various functions to fulfill project milestones and deliverables, keeping stakeholders informed of progress, risks, and issues.

⛳️ Requirements

• Extensive experience in clinical research and study initiation.

• Proficient understanding 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 requirements, and clinical trial start-up procedures.

• Exceptional oral and written communication skills in English.

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

• Capability to work independently, prioritize multiple tasks, and make informed decisions in uncertain situations.

• Experience in global, matrix, and multicultural settings.

• Keen attention to detail and a strong focus on quality.

• Dedication to meeting project timelines.

• A Bachelor's degree in Life Sciences, Pharmacy, Nursing, or another health-related field, or equivalent experience, is preferred.

🏝️ Benefits

• Flexible home-based work options.

• Support from a dedicated line manager.

• A closely-knit team environment.

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

• A flexible work culture.

• Opportunities for professional growth.