Clinical Trial Assistant

Description

The CTA (Clinical Trial Assistant) is an experienced level or associate level (junior level) position responsible for performing a variety of research, data base and clerical duties of a complex and technical nature in support of multiple clinical trials. This position also provides administrative support to clinical teams by reviewing vendor invoices for accuracy against budget, tracking vendor payments in compliance with federal regulations and taking meeting minutes during project team meetings.

Key Responsibilities

• Overall responsibility of Trial Master File (TMF) : set up, maintenance and archiving for in-sourced or outsourced studies
• For out-sourced studies, controls administrative work ensuring CRO maintains a complete trial master file and organized shipment to Galderma in the appropriate format at the end of the study
• For in-sourced studies, assures filing on an ongoing basis of a complete TMF (including insurance, translations, approvals, etc.)Completes TMF Quality Control and subsequent Quality Assurance audit resolution including drug reconciliation documentation in collaboration with Clinical Team
• Assures administrative archiving of the TMFEnsures consistency and set up between all outsourced studies to our TMF structure
• Assist in study set-up activities (regulatory binders, investigator meetings, presentations, CDAs, agreements, insurance, etc.)
• Serve as the contact and / or liaison for the CRO and Investigative sites for regulatory documents, clinical supplies, CRFs, study agreement (financial contract), and other pertinent administrative matters, under the supervision of the CPM or delegated CRA
• Process invoices and Investigator payments after appropriate approval obtained by Clinical Project Manager
• Assemble final report appendices; ensure final report completeness in collaboration with Clinical team.
• Work on a Global Project Team and interface with Europe and Global counterparts, as needed
• Responsible for set up of public registries and maintenance.
• Other duties as assigned

Preferred Skills and Qualifications

What We Offer in Return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next Steps

Our people make a difference

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do

Employer’s Rights :

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.