Clinical Research Assistant
hace 2 semanas
Covance Latinoamérica: A Leader in Clinical Research
We are seeking a highly skilled Clinical Research Assistant to join our team in Mexico. As a Clinical Research Assistant, you will play a critical role in the success of our clinical trials.
Key Responsibilities:
- Act as contact for project team and study sites.
- Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
- Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
- Assist with the management of study supplies and organize shipments.
- Create, update, track, and maintain study-specific trial management files, tools, and systems.
- Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings).
- Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
- Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
- Provide input in writing Monitoring Conventions as assigned.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
Requirements:
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
- Basic understanding of biology and biological processes.
- Good organizational and time management skills.
- Good communication skills, oral and written.
- Exhibit general computer literacy.
- Works efficiently and effectively in a matrix environment.
- Fluent in local office language and in English, both written and verbal.
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