Clinical Research Specialist
hace 2 semanas
Covance Latinoamérica is growing, and we're looking for a talented Clinical Research Assistant to join our team.
Responsibilities
As a Clinical Research Assistant, you will be responsible for providing support to our project team and study sites. This includes:
• Acting as a contact for project team and study sites.
• Performing 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.
• Assisting with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
• Assisting with the management of study supplies and organizing shipments.
• Creating, updating, tracking, and maintaining study-specific trial management files, tools, and systems.
• Assisting 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).
• Coordinating meetings with clients, investigators, and project team, including taking minutes.
• Ensuring compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
• Providing input in writing Monitoring Conventions as assigned.
• Assisting in submissions and notifications to Ethics Committees and Regulatory Authorities.
Requirements
To be successful in this role, you will need:
• A 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.
About Covance Latinoamérica
Covance is an equal opportunity employer and values diversity in the workplace. Your privacy and confidentiality are important to us.
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