Clinical Research Associate I
hace 4 días
About Psi Cro
We are a dynamic, global company that cares for our staff, clients, partners, and the quality of our work. Founded in 1995, we bring together over 2,800 driven individuals who change lives by bringing new medicines to those who need them.
Job Description:
This role is responsible for being the main point of contact between site personnel and Clinical Research Associates (CRAs) involved in projects. Key responsibilities include query resolution, EDC completion, and managing vendors, study supplies, and access management.
Main Responsibilities:
Ensure pre-study testing of local site facilities is completed, including scans, MRI/CT qualification questionnaires, and test ECGs.Manage clinical supplies, including ordering, receipt, inventory storage, distribution, return/recall, and reconciliation.Coordinate regulatory and ethics committee submissions and notifications, staying up-to-date on local regulations.Prepare for and follow up on site, TMF, and systems audits and inspections.Manage the Trial Master File (TMF) at a site and country level, ensuring documents are regularly filed, prepared, distributed, and updated.Arrange and track initial and ongoing project training for site teams in vendor-related systems.Document Management and translations status review of the study.Ensure proper safety information flow with investigative sites.Requirements:
To be successful in this role, you will need a College/University Degree in Life Sciences and administrative work experience, preferably in an international setting. Prior experience working as a CTA for CROs and in Clinical Research is also required. Local regulations knowledge and full working proficiency in English and Spanish are essential.
Additional Information:
This role offers opportunities to advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company. The estimated salary range for this position is $45,000 - $60,000 per year, depending on location and experience.
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