The 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.

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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 career with an 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. xugodme

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.

📌 Clinical Research Associate (España)
🏢 Opis
📍 España