Clinical Research Associate
hace 4 semanas
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. 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 20.000 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 20.000 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 start-up. 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 follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study. Verify study documents (., 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 trial-related documentation. Assist with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). And you will review and track study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. Assist in the coordination and planning of meetings (. Investigator Meetings, Kick-off meetings) and you will prepare accurate and complete meeting minutes for various meetings. Identify and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. Review, clarify and obtain, data changes via query resolutions with site personnel. Conduct monitor training.WHO YOU ARE
You have a Life Sciences Degree. Master Degree in Clinical Development would be a plus You have a minimum of 2 years in a similar role in international CRO or pharmaceutical company overseeing/managing international studies You have a Native level of Spanish and Advanced in English You have good knowledge of Microsoft Office, eTMF, and EDC platforms. You have basic ability to use MS Office Suite. You have basic knowledge of ICH/GCP Guideline. You have the ability to work on assignments with a diverse scope. You have the ability to establish rapport with site personnel/ colleagues. You have a basic knowledge of electronic data capture (EDC) systems. You have a basic knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. You have a basic knowledge of the therapeutic areas assigned. You have ability and willingness to travel. You have the ability to work both in a team and independently. You have the ability to meet deadlines and prioritize based on study needs.WHAT WE OFFER
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at . If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply
We look forward to receiving your application
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