Clinical Research Associate II (CRA II)
Location: Mexico City
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
As a Clinical Research Associate at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
The role
- Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
- Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
- Managing sponsor generated queries
- Taking responsibility for study cost effectiveness
- Preparation and review of study documentation and feasibility studies for new proposals
- Potential to assist in training and mentoring fellow CRAs
- Maintain timelines . Ensure accuracy and completeness of data entered into ICON systems.
- Independent and proactive coordination of all the necessary activities required to set up and monitor a study , including but not limited to the following : Identify investigators. Help when requested , in preparation of regulatory submissions . Design of patient information sheets and consent forms .
- Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits.
What you need
- University degree in medicine, science, or equivalent
- At least 18 months of Independent/On-site monitoring experience is required
- Previous monitoring experience in medium sized studies, including study start-up and close-out
- Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent written and verbal communication
- Ability to work to tight deadlines
- Availability to travel at least 60% of the time .
Why join us?
Ongoing development is vital to us, and as a CRA you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.
ICON Plc is an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
For more information about personal rights under Equal Employment Opportunity, visit:
EEO is the Law
EEOC Poster