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About PSI CRO
PSI CRO is a leading Contract Research Organization with over 25 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering high-quality and on-time services across a variety of therapeutic indications.
Job Summary
We are seeking an experienced Clinical Research Associate to join our team as a trainer and coordinator for junior CRAs. In this role, you will have the opportunity to develop yourself as a trainer, mentor, and leader, while contributing to the success of our clients and employees.
Key Responsibilities
- Conduct and report all types of onsite monitoring visits, ensuring compliance with regulatory requirements and company standards.
- Be involved in study startup, including site selection, feasibility assessment, and initiation visits.
- Perform CRF review, source document verification, and query resolution, ensuring data accuracy and integrity.
- Manage site communication and relationships, ensuring timely and effective issue resolution.
- Serve as a point of contact for in-house support services and vendors, providing technical assistance and guidance as needed.
- Communicate with internal project teams regarding study progress, providing updates and insights to inform decision-making.
- Participate in feasibility research, identifying potential sites and assessing their suitability for clinical trials.
- Support the regulatory team in preparing documents for study submissions, ensuring compliance with regulatory requirements.
Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
- Independent on-site monitoring experience in Mexico, with a strong understanding of local regulations and guidelines.
- Experience in all types of monitoring visits in Phase II and/or III, with a focus on Oncology or Infectious Diseases.
- Availability to travel, with a valid passport and ability to obtain necessary visas.
- Full working proficiency in English and Spanish, with excellent communication and interpersonal skills.
- PC skills to work with MS Word, Excel, and PowerPoint, with experience in clinical trial management software.
- Ability to plan, prioritize, and manage multiple tasks and projects, with a focus on quality and timeliness.
- Strong problem-solving and analytical skills, with the ability to think critically and make sound decisions.
What We Offer
As a Clinical Research Associate at PSI CRO, you will have the opportunity to develop a wide range of skills, from training and development to site management and regulatory compliance. You will work with a knowledgeable and professional team, contributing to the success of our clients and employees. We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development.
