Clinical Project Associate

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The Clinical Project Associate is in charge of assistance and support to all clinical research activities related to the projects assigned.

• Assistance to the Clinical Project Manager in the preparation, execution and closure of clinical trials.
• Assistance to the members of the project team in administrative, logistical and practical tasks, including follow-up, collection, distribution and presentation of the study documentation.
• Ensure adequate tracking and monitoring of all activities, documents and reports with the required format for delivery within the agreed deadlines.
• Request and review regulatory documents as required.
• Participate in the development of the study and the implementation of the process, including drafting and revision of study documents; clinical trial planning, ICFs, eCRF, organization and presentation at investigators meetings, and / or development of specific CRA project trainings.
• Support in the preparation of shipment of supplies related to the clinical trial.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs / all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Conduct oversight visits for monitoring if required.
• Follow up and supervise the data collection of the ongoing study.
• Contribute to ensure effective project plans are in place for the study.
• Contribution to Monitoring and resolution of audit findings.
• Review financial issues and bill payments as defined in the study contracts.
• Scalate important topics or any potential quality issues to Clinical Project Manager and Clinical Operations Manager.
• Attend study meetings and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

Searched profile : Training :

University Degree in Health Sciences. Post-graduate studies in clinical research will be very valuable.

Languages :

Spanish : High level in reading, speaking and writing.

English : high level in reading, speaking, and writing (B2 or higher).

Experience :

At least 1 year in Clinical Research

Skills / Competence :

Excellent organizational and communication skills.

MS Office (intermediate-high level).

Occasional travel.

Seniority level

Employment type

Job function

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