CRA II/Senior CRA en InVentiv Health Clinical

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CRA II/Senior CRA

Fecha de la oferta: 21 Abr.
Empresa que publica esta oferta: InVentiv Health Clinical
Ver todas sus ofertas de empleo (4)
InVentiv Health Clinical nacida con la vocación de seleccionar los mejores perfiles profesionales del mercado, para ponerlos a disposición del sector farmacéutico. Para inVentiv Health Clinical,cada candidato supone una inversión en concepto de equipo humano, siendo este en todo momento el mayor valor de la compañía y la garantía más segura para el éxito de nuestros clientes.Nacida de la fusión de varias compañía como i3 Pharmaceutical Services y PharmaNet, se convierte en la empresa n 1 del mundo en Outsourcing de personal para investigación clínica
Número de vacantes: 1
Provincia/s: Barcelona, Madrid

Descripción

Descripción: At inVentiv Health Clinical we are currently looking for 2 CRAs II/Senior CRAs to join our company.

Your responsibilities will be the following:

•Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
•Review completion of proper informed consent procedures.
•Ensure accurate data reporting via review of site source documents and medical records.
•Interpret data to identify protocol deviations and risks to subject safety/data integrity.
•Generate queries and manage resolutions with site personnel.
•Perform investigational product accountability as per the protocol and Study Monitoring Plan.
•Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
•Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
•Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
•Understand project scope, budgets
•Act as primary liaison with study site personnel.
•Enter data into tracking systems as required.
•Participate in the identification and selection of investigators and clinical sites.
Edad máxima para el puesto: 65 años.

Requisitos

Requisitos: We are looking for candidates with the following characteristics:

•Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
•Minimum of one to two years prior clinical monitoring experience
•Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
•Strong organizational skills
•Must demonstrate good computer skills.
•Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
•A good command of the English language both verbal and written
•Ability to travel as necessary up to 70% depending on assignment.
Nivel de estudios mínimo requerido: Licenciado en Ciencias de la Salud
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 2 años
Disponibilidad para viajar requerida: El 60% del tiempo laboral

Comparte esta oferta:

Esta oferta ha recibido 37 inscripciones.