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