# Study Start-Up CRA II at ICON Plc **Company**: ICON Strategic Solutions **Location**: Mexico City **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Mexico-Mexico-City/SSU-CRA-2_JR160658?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_dabbef12-184 ## Description At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As a Study Start-Up CRA II at ICON Plc, you will oversee and manage site start-up and activation activities to ensure clinical trials are initiated efficiently and in compliance with protocol requirements, local regulations, and industry standards. **What You Will Do:** You will lead study start-up activities requiring technical expertise in site activation, regulatory submissions, and clinical trial operations, with a focus on quality, compliance, and timely delivery. Key responsibilities include: - Managing site start-up and activation activities to ensure sites are activated according to study timelines and sponsor expectations. - Preparing, reviewing, and coordinating submissions to Ethics Committees and regulatory authorities in accordance with local requirements and ICH-GCP guidelines. - Ensuring compliance with current local regulations, including recent COFEPRIS updates and requirements impacting clinical trial start-up in Mexico. - Collaborating with investigative sites to collect, review, and maintain essential regulatory documentation required for site activation. - Working closely with cross-functional teams to identify and resolve start-up challenges and ensure successful study delivery. - Leveraging prior site monitoring experience to assess site readiness and proactively identify operational risks. - Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth study start-up activities. **Your Profile:** You will have a strong foundation in Study Start-Up and Site Activation activities, combined with previous CRA monitoring experience and a thorough understanding of the Mexican regulatory environment. Required qualifications and experience: - Bachelor's degree in a relevant scientific discipline or healthcare-related field. - Strong experience in Study Start-Up and Site Activation activities within a CRO, sponsor, or clinical research organization. - Previous Clinical Research Associate (CRA) monitoring experience, with a solid understanding of site management and clinical trial conduct. - Strong knowledge of ICH-GCP, Ethics Committee processes, essential document management, and clinical trial start-up requirements. - Up-to-date understanding of COFEPRIS regulations and recent regulatory changes impacting clinical trial submissions and site activation in Mexico. - Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. - Experience working with clinical trial systems, including CTMS and eTMF platforms. - Excellent communication, interpersonal, and stakeholder management skills, with the ability to collaborate effectively within global cross-functional teams. - Based in Mexico City, Mexico. - Willingness to travel as required (approximately 25%). **Rewards & Benefits** ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: - Competitive base salary and performance related incentives - Health and wellbeing programmes including medical, dental, and vision coverage where applicable - Retirement and pension plans - Life assurance and disability coverage - Employee assistance programmes and wellbeing resources - Learning and development opportunities through structured training and career pathways ## Skills ### Required - ICH-GCP - COFEPRIS - Clinical Research Associate - CTMS - eTMF - Spanish --- Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Mexico-Mexico-City/SSU-CRA-2_JR160658?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)