- You will provide full coordination, tracking and administrative support to global clinical research teams to ensure effective and efficient conduct of international clinical research studies for Grifols.
- You will provide support and assistance to Clinical Research Associate (s), Program Manager(s) and Program Leader(s) in the execution of clinical trials. This includes maintaining the Trial Master File (TMF) in an inspection-ready state, assisting with site management, set up the Investigator's File, initiating collection, archiving, periodically reviewing, maintaining, and tracking essential documents throughout the life-cycle of the trial, ensuring GCP compliance.
- Working closely with the different internal team members and third party vendors, you will assist with the planning, preparation, scheduling and on-site support of investigators meetings, as well as preparing executive summaries, newsletters, and meeting minutes.
- You will be responsible for assisting in the drafting and distribution of key clinical study-related documents, such as investigator brochures, protocols, informed consents, and regulatory submissions.
- According to the clinical project, you will be asked to coordinate Clinical Research Organizations (CRO) and vendors to verify the validity of the documentation received, tracking it, ensuring that all required site documentation has been obtained on time.
- You will assist in activities associated with quality control audits and regulatory inspections.
- You will assist the Study Team in regulatory-related activities (IEC/IRBs/CA) including submissions and amendments to Ethic Committees and Regulatory Authorities.
- You will assist with document translations.
- You will assist project teams with trial progress tracking and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
- Health Science Degree (Medicine, Pharmacy, Nurse) or Bioscience (Biochemistry, Biotechnology, Biology or similar).
- High and proven knowledge in electronic trial master file (TMF) management.
- Experience of at least 1 year in a CRO or pharmaceutical company in a Clinical Research Department is a plus.
- Advanced level of English (C1).
- Detail-oriented.
- Excellent written and verbal communication skills.
- Ability to work independently.
- Proactive and positive approach to problem solving.
- Time management and organizational skills.
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Clinical Trial Assistant - Sant Cugat del Vallès, España - Grifols
Descripción
¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
From the Clinical Operations department we are looking for a Clinical Trial Assistant.
Your main mission will be to provide administrative support to the clinical team and to be accountable for the Electronic Trial Master File.
What your responsibilities will be
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
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
