Clinical Research Associate

OPIS; Madrid; Presencial; EUR 29.000 - 48.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Additional benefits

Career development

Descripción de la vacante

OPIS is seeking a Clinical Research Associate to manage and monitor multi-country trials in compliance with study protocols, ICH-GCP, and applicable regulations. You will oversee site selection, initiation, monitoring, and close-out activities while ensuring data quality and patient safety, reporting to the Clinical Project Manager.

The role requires a scientific degree, at least two years in CRA or trial monitoring (oncology/phase 1 preferred), and strong knowledge of ICH-GCP and ISO14155.

Formación

• Degree in a scientific field is required.
• Minimum 2 years’ CRA or clinical trial monitoring experience (oncology and phase 1 studies highly desirable).
• Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes.
• Good English and Microsoft Office skills.
• Strong organizational, communication, and problem-solving abilities.
• Ability to work independently and in a team.

Responsabilidades

• Identify, assess, and initiate investigational sites.
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.
• Perform source data verification and ensure data accuracy and completeness.
• Monitor patient recruitment and support sites in meeting targets.
• Ensure proper reporting of adverse events and protocol deviations.
• Manage investigational product handling, storage, and accountability.
• Maintain study documentation (TMF/eTMF, Investigator Files).
• Write monitoring reports and follow-up communications.
• Collaborate with project teams, sponsors, and site staff.
• Support audits/inspections and mentor junior CRAs.

Conocimientos

Good English

Communication skills

Teamwork

Independence

Educación

Degree in scientific field

Herramientas

Microsoft Office

Descripción del empleo

Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.

Key Responsibilities

• Identify, assess, and initiate investigational sites
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
• Perform source data verification and ensure data accuracy and completeness
• Monitor patient recruitment and support sites in meeting targets
• Ensure proper reporting of adverse events and protocol deviations
• Manage investigational product handling, storage, and accountability
• Maintain study documentation (TMF/eTMF, Investigator Files)
• Write monitoring reports and follow-up communications
• Collaborate with project teams, sponsors, and site staff
• Support audits/inspections and mentor junior CRAs

Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager.

Key Responsibilities

• Identify, assess, and initiate investigational sites
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
• Perform source data verification and ensure data accuracy and completeness
• Monitor patient recruitment and support sites in meeting targets
• Ensure proper reporting of adverse events and protocol deviations
• Manage investigational product handling, storage, and accountability
• Maintain study documentation (TMF/eTMF, Investigator Files)
• Write monitoring reports and follow-up communications
• Collaborate with project teams, sponsors, and site staff
• Support audits/inspections and mentor junior CRAs

Requirements

• Degree in a scientific field
• Minimum 2 years’ CRA or clinical trial monitoring experience (oncology and phase 1 studies highly desirable)
• Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes
• Good English and Microsoft Office skills
• Strong organizational, communication, and problem-solving abilities
• Ability to work independently and in a team

What we offer

• Salary up to EUR 48,000/annually based on experience
• Additional benefits
• Opportunity to develop your career with and expanding company

Please read the information notice on the processing of personal data in the candidates information section of our company website.

Who we are

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.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.