Clinical Research Coordinator

hace 6 días


Ciudad de México, Ciudad de México Covance Latinoamérica A tiempo completo

Company Overview:
Covance Latinoamérica is expanding its operations, providing a dynamic opportunity within a rapidly growing sector of our organization.

Key Responsibilities:

• Serve as the primary liaison for project teams and study sites.

• Conduct Case Report Form (CRF) evaluations, generate queries, and resolve discrepancies according to established data review protocols, under direct supervision using Covance or client data management systems.

• Support the creation and reconciliation of queries directed to investigative sites or clients to address data issues.

• Aid in the oversight of study materials and coordinate shipments.

• Develop, update, monitor, and maintain study-specific trial management documentation, tools, and systems.

• Assist local project team members with various administrative tasks as needed, including investigator payments, client correspondence, status report preparation, and organizing investigator meetings.

• Organize meetings with clients, investigators, and project teams, including minute-taking.

• Ensure adherence to Covance Standard Operating Procedures (SOPs), FDA, ICH, and Good Clinical Practice (GCP) regulations in all daily activities.

• Contribute to the drafting of Monitoring Conventions as assigned.

• Assist in the preparation and submission of documents to Ethics Committees and Regulatory Authorities.

On-Site Monitoring Duties:

• Support Senior Clinical Research Associates (CRAs), CRA-2, and CRA-1 with on-site responsibilities as per training objectives (e.g., reviewing Case Report Forms and Study File Notebooks, managing drug accountability).

• Initiate, oversee, and conclude clinical investigative sites under the direct supervision of Clinical Research Associates 1 and 2, Senior Clinical Research Associates, Project Managers, or Project Directors.

• Perform additional tasks as directed by management.

Qualifications:

• A university or college degree in a relevant field (life sciences preferred) or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology). Candidates with one or more years of relevant clinical research experience in the pharmaceutical or Contract Research Organization (CRO) sectors may also be considered.

Experience:

• Fundamental understanding of biological sciences and processes.

• Strong organizational and time management capabilities.

• Effective communication skills, both verbal and written.

• Proficient in general computer applications.

• Ability to work efficiently and effectively within a matrix environment.

• Fluency in the local office language and English, both written and spoken.



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