Initiation Clinical Research Associate – iCRA

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

📋 Description

• Oversee site initiation activities from feasibility assessments and qualifications to activation.

• Cultivate robust relationships with investigators and site personnel.

• Prepare, review, negotiate, and finalize regulatory and site documents, including CDAs, ICFs, translations, and amendments.

• Coordinate submission processes and secure approvals with IRBs/IECs, Ministries of Health, and Regulatory Authorities.

• Develop and monitor activation strategies, timelines, and regulatory plans.

• Ensure high-quality documentation within CTMS, eTMF, and TMF systems, prioritizing First Time Quality (FTQ).

• Detect, address, or escalate any site-related issues and risks concerning activation, recruitment, compliance, training, and data quality.

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

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

• Uphold compliance with ICH-GCP guidelines, local regulations, sponsor requirements, and Parexel SOPs.

• Collaborate with various functions to meet project milestones and deliverables while proactively communicating on progress, risks, and issues.

⛳️ Requirements

• Extensive experience in clinical research and study startup processes.

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

• Capability to work autonomously, prioritize multiple responsibilities, and make decisions in uncertain circumstances.

• Proficient knowledge of CTMS, eTMF, TMF, and Microsoft Office applications.

• Experience in global, matrixed, and multicultural environments.

• Strong attention to detail, commitment to quality, and dedication to meeting project deadlines.

• Excellent proficiency in English, both spoken and written.

• A Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or another health-related discipline (or equivalent experience) is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options available.

• Supportive and inclusive company culture.