Snr Clin Trials Admin

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

The Clin Trials Admin/Snr Clin Trials Admin is responsible for providing support to the clinical study team for the set up and administration of electronic Trial Master File (eTMF) ensuring adherence to protocol, Good Clinical Practices (GCP) guidelines and company Corporate and Local Standard Operating Procedures (SOPs).

The Clin Trials Admin/Snr Clin Trials Admin is part of the study team and will collaborate with the people involved in the conduct of the registries from the start-up, up to the closing and archiving activities. Clin Trials Admin/Snr Clin Trials Admin will interact with the clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site’s staff, when applicable, to ensure that all the administrative tasks are completed in a timely manner.

Essential duties:
TMF- Responsible for the eTMF set up system for the Rare Disease Registries- Set-up, manage and keep the local trial master files (paper & electronic) up-to-date in association with the CPL and CRAs in accordance with the applicable SOPs for filing of trial documents in such a way that any relevant information can be presented promptly during audits and inspections.- Manage the upload of documents for all existing and new sites and ensure a primary Quality control (QC).- Ensure correct and proper classification of the documents in the eTMF system- Control study team compliance to ensure TMF inspection-readiness at any time- To ensure completion and tracking of the volume of documents uploaded in the system- Responsible for TMF archiving process -Preparation of archiving, collection, reconciliation and filing of relevant documents.

Focus on Customer- Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors- Effective relationship management, sites, and study teams, participate to team spirit and motivation

Pursue Scientific and Process Excellence- Good attention to detail- Methodical approach to work and prioritization of tasks- Understanding of the principles of ICH-GCP and applicable local regulatory requirementsWork with Others- Good organizational skills- The ability to communicate effectively in English.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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