Clinical Research Associate

hace 1 semana


Bogotá, Bogotá D.E., Colombia Psi Cro A tiempo completo

Job Title: Site Management Associate I
Job Summary: We are seeking a highly skilled Site Management Associate I to join our international team at Psi Cro. This role will play a crucial part in the success of our clinical research projects, ensuring seamless communication, system maintenance, and document management.

Main Responsibilities:
Communication and Coordination: Serve as the primary point of contact between site personnel and CRA involved in the project, ensuring timely query resolution and EDC completion.
Vendor Management: Act as the site's main contact for vendors, study supplies, and access management, ensuring smooth interactions and timely resolutions.
Pre-Study Testing: Ensure that pre-study testing, including scans, MRI/CT qualification questionnaires, and test ECGs, is completed for local site facilities.
Site Event Tracking: Assist monitors in completing all subject event and site event information in CTMS, ensuring timely tracking and resolution of site issues and action items.
Clinical Supplies Management: Oversee the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies, ensuring compliance with regulations and standard operating procedures.
Regulatory and Ethics Submissions: Ensure timely regulatory and ethics committee submissions and notifications, staying up-to-date on local regulations and dispositions.
Audit and Inspection Preparation: Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections, ensuring compliance with regulatory requirements.
Document Management: Manage the TMF on a site and country level, ensuring regular filing and documentation of study-related materials.

Requirements:
Education: College/University Degree in Life Sciences or a related field.
Experience: Administrative work experience, preferably in an international setting, with prior experience working as a CTA for CROs and in clinical research.
Language Skills: Full working proficiency in English and Spanish, with proficiency in MS Office applications.
Soft Skills: Ability to plan and work in a dynamic team environment, with excellent communication and collaboration skills.

About Us: Psi Cro is a dynamic, global company founded in 1995, bringing together over 2,800 driven, dedicated, and passionate individuals who work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.



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