Clinical Research Associate

Opis S.r.l.; Lucca; Remoto; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

Un leader de la biotechnologie en Italie recherche un Clinical Research Associate pour gérer et superviser des essais cliniques à distance. Ce poste exige une formation en sciences et au moins 2 ans d'expérience. Le candidat travaillera en étroite collaboration avec les équipes de départ et assurera la conformité réglementaire. Vous bénéficierez d'un salaire compétitif et d'opportunités de carrière dans une entreprise en pleine croissance.

Servizi

Salaire compétitif

Opportunité de développement professionnel

Competenze

• Au moins 2 ans d'expérience dans la gestion et la conduite d'essais cliniques.
• Capable de réaliser indépendamment toutes les activités liées à la surveillance des essais cliniques.
• Enthousiaste, informé et proactif.

Mansioni

• Coordonner et superviser l'exécution des études et essais cliniques.
• Effectuer des visites de site selon les procédures et délais prévus.
• Assurer la conformité des documents et la progression des études attribuées.

Conoscenze

Connaissance approfondie des principes ICH GCP

Compétences en communication écrite et verbale

Compétences organisationnelles et de résolution de problèmes

Formazione

Diplôme universitaire dans un domaine scientifique / des sciences de la vie

Strumenti

Office Suite (Word, Excel, PowerPoint)

Descrizione del lavoro

As a Clinical Research Associate (CRA) you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.

This is a Remote (work from home) position.

Some of what you will do :

• Identify investigator sites and participate in the feasibility process for new studies
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
• Perform visits remotely according to foreseen applicable procedures and timeframes
• Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission
• Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan / projections and motivate Investigators to achieve the targets
• Check the correct submission and completion of informed consent forms
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
• Verify that serious adverse events have been reported using a SAE form, according to OPIS and / or Sponsor procedures
• Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

Requirements :

• Enthusiastic, knowledgeable and proactive
• University degree in a scientific / life science field
• At least 2 years of experience in managing and conducting clinical trials
• In depth knowledge of ICH GCP principles
• Able to carry out independently all the activities related to the monitoring of clinical trials
• Good knowledge of Office Suite (Word, Excel, PowerPoint)
• Organizational and problem-solving skills
• Excellent written and verbal communication skills including good command of English language

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

We offer a competitive salary with other benefits and opportunity to develop your professional career with an expanding and growing company.

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Clinical Research Associate • lucca, Italia