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Clinical Research Associate
hace 3 meses
We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over employees in 30 countries.Grifols' three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
With the world's largest network of plasma donation centers, Grifols, through its Bioscience Division, is a leading producer of essential plasma-derived medicines for the treatment of rare, chronic, and sometimes life-threatening conditions.
To help ensure a reliable and consistent source of plasmaderived medicines worldwide, we have an integrated production process that begins with plasma collection and continues through fractionation and purification at our three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California).
Key products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty products.Help us lead one of the world's largest pharmaceutical companies.
We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over people.
From the Clinical Development department we are looking for a Clinical Research Associate.YOUR TASK AND RESPONSABILITIES
As a Clinical Research Associate you will provide support in the oversight and management of vendors.
You will conduct clinical monitoring to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols and you will assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study.
You will able to:
- Review and track comments of monitoring reports generated by CRO as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities in conformance to the clinical trial protocol, company SOPs, GCP/ICH Guidelines and all applicable regulatory requirements.
- Perform Sponsor Site Visits as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities in conformance to the clinical trial protocol, company SOPs, GCP/ICH Guidelines and all applicable regulatory requirements.
- Assist in the management of vendor performance during conduct of the study.
- Assist with expedited identification, retrieval, and review of study documents particularly those required for site activation/study startup.
- Conduct/oversee completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study.
- Prepare telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and followup letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
- Verify study documents (e.g., case report forms, source documents, and adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
- Reconcile clinical supplies and drug accountability records at study sites.
- Communicate and interact with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
- Assist with effective and timely audit/inspection responses.
- Perform regulatory document review and approval for IP release.
- Monitor processes for distribution and tracking of SAE's, safety documentation, and pregnancies.
- Collaborate with data management to resolve queries.
- Facilitate investigator site payments, as applicable.
- Review/create/track trial newsletters, memos, mass correspondence, or other appropriate trialrelated documentation.
- Assist with auditing of study files and retrieval of outstanding documents as needed (inhouse and onsite document reconciliation).
project files both electronically and in the Trial Master File and Project Status Reports.
- Assist in the coordination and planning of meetings (e.g. Investigator Meetings, Kickoff meetings) and you will prepare accurate and complete meeting minutes for various meetings.
- Identify and effectively d
