Site Management Associate I
Psicro👥 1001 - 5000 employees🏢 Pharmaceuticals
Support clinical research projects by managing communication, documentation, and regulatory compliance while serving as the main contact for site personnel and vendors.
Site Management Associate I
🕒 12 days ago
📍 🇲🇽 Mexico City - Hybrid🎹 Mid-level🏥 Clinical Operations Specialist📢 🇬🇧 English Required💼 Full-Time
Clinical ResearchCommunicationDocumentation ManagementRegulatory Compliance
📜 Description
- Streamline communication between site personnel and CRA for query resolution and EDC completion.
- Serve as the primary contact for vendors, study supplies, and access management.
- Ensure completion of pre-study testing for local site facilities.
- Assist Monitors with subject and site event information in CTMS.
- Manage clinical supplies including order, receipt, inventory, and distribution.
- Coordinate regulatory submissions and ensure compliance with local regulations.
🛠️ Requirements
- College/University Degree in Life Sciences;
- Administrative work experience, preferably in an international settings;
- Prior experience working in Clinical Research;
- Local regulations knowledge;
- Full working proficiency in English;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Full job description
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
Only CVs in English will be accepted.
Hybrid position in Mexico City.
You will be responsible for:
- Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.
- Serves as the primary sites’ contact point for vendors, study supplies, and access management.
- Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
- Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.
- Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
- Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
- Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.
- Manage the TMF on a site and a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
- Arrange and track initial and on-going project training for site teams in all vendor-related systems.
- Document Management and translations status review of the study.
- Ensures proper safety information flow with investigative sites.
Qualifications
- College/University Degree in Life Sciences;
- Administrative work experience, preferably in an international settings;
- Prior experience working in Clinical Research;
- Local regulations knowledge;
- Full working proficiency in English;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Additional Information
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.
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