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hace 2 meses
We are seeking a highly motivated and organized Clinical Research Assistant to join our team in Mexico. As a Clinical Research Assistant, you will play a key role in the success of our clinical trials by providing administrative support to our project team and study sites.
Key Responsibilities:- Act as the primary point of contact for project team members and study sites, ensuring seamless communication and coordination.
- Perform thorough reviews of Case Report Forms (CRFs) and generate queries to resolve data discrepancies, under the guidance of senior team members.
- Assist in the management of study supplies, including organizing shipments and ensuring timely delivery.
- Develop and maintain study-specific trial management files, tools, and systems, ensuring accuracy and efficiency.
- Provide administrative support to local project team members, including preparing status reports, coordinating meetings, and ensuring compliance with regulatory requirements.
- Ensure adherence to Covance Standard Operating Procedures (SOPs), FDA, ICH, and GCP regulations in all aspects of daily work.
- Collaborate with senior team members to develop Monitoring Conventions and assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
- Support Senior CRAs, CRA-2, and CRA-1 with on-site tasks, including reviewing CRFs and Study File Notebooks, and ensuring drug accountability.
- Initiate, monitor, and close out clinical investigative sites under the supervision of Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers, or Project Directors.
- University or college degree in a life science or related field, or certification in a related allied health profession from an accredited institution.
- Alternatively, candidates with one or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
- Basic understanding of biology and biological processes.
- Excellent organizational and time management skills.
- Strong communication skills, both written and verbal.
- Proficiency in computer software and systems.
- Ability to work efficiently in a matrix environment.
- Fluency in English and local office language, both written and verbal.
Covance Latinoamérica is a leading provider of clinical research services, and we offer a dynamic and supportive work environment. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.
