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Oferta publicada el 17 de Junio

Clinical Research Associate

Esta oferta ha recibido 44 visitas

Madrid, España

Vacantes: 1

Empresa que publica la oferta: PHARM-OLAM

pharm olam

Descripción de la oferta

Descripción:

La CRO global, Pharm-Olam, precisa incorporar un/a Clinical Research Associate para su equipo en Madrid.

Summary: 

Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).

Responsibilities:

  • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Pharm-Olam SOPs for monitoring requirements.
  • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Collects and reviews regulatory documents as required.
  • Prepares site visit reports and telephone contact reports.
  • May participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings.
  • Resolves site issues, including site recruitment challenges, and determines status for IP shipment.
  • Works with Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA), regulatory team members or sponsor to secure authorization of regulatory documents and site contracts.
  • Informs team members of completion of regulatory and contractual documents for individual sites.
  • Attends Investigator Meetings (IM) and study specific training meetings.
  • May translate, coordinate translations or review completed translations of critical documents.
  • Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed.
  • Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required.
  • Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.
  • Provides secondary in-house review of CRFs/eCRFs (if required).
  • Works both independently and in a team environment.

Working Relationship: 

  • Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager.
  • Collaborates with Pharm-Olam project team members.
  • Collaborates with Pharm-Olam and local support personnel.
  • Liaises with Investigators, Site Staff, and Regulatory Authorities and Ethics Committees.
  • Liaises with Sponsor scientific and medical personnel.
  • Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organizations.
  • Liaises with Quality Assurance personnel.

Tipo de contrato:

Indefinido

REMUNERACIÓN / AÑO:

According to the position.

VENTAJAS SOCIALES / ECONÓMICAS:

Requisitos de la oferta

Requisitos:

  • At least two years clinical monitoring experience or relevant clinical trial experience.
  • Relevant life science degree / medical / nursing background or equivalent.
  • Customer service orientation.
  • Sound knowledge of medical terminology and clinical monitoring process.
  • Attention to detail.
  • In-depth therapeutic and protocol knowledge
  • Ability to perform travel for 3-4 days on site per month, depending on project needs.
  • Excellent communication in English in both written and verbal skills.
  • Computer literate and proficient in Microsoft Office.
  • Excellent interpersonal and organizational skills.
  • Ability to work independently and to effectively prioritize tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients.
  • Ability to manage multiple projects.
  • Ability to develop, organize and manage new skills and tasks.

NIVEL MÍNIMO DE ESTUDIOS:

Licenciatura

EXPERIENCIA PROFESIONAL MÍNIMA:

2 años

DISPONIBILIDAD PARA VIAJAR:

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