Clinical Research Associate

We are looking for a motivated Clinical Research professional to join our Clinical Operations team.

This role is designed for someone with a scientific/life sciences degree and initial experience in clinical research, such as a Clinical Trial Assistant (CTA), Clinical Research Coordinator, Study Coordinator or similar position, who is looking to develop their career into a CRA role.

The successful candidate will initially work as a non-certified CRA, receiving the required induction and clinical research training, including the CRA course where applicable.

Once the required training and CRA certification have been successfully completed, the role will progress into a CRA position, with responsibility for monitoring clinical studies.

Key responsibilities

• Support the planning, set-up and conduct of clinical studies, primarily observational studies and clinical investigations.
• Support site identification, selection, initiation and close-out activities.
• Develop knowledge and practical experience in clinical trial monitoring under the supervision of a Project Manager.
• Support on-site and remote monitoring activities in accordance with study protocols, SOPs, ICH-GCP and applicable regulations.
• Maintain communication with investigators and site staff and follow up on study-related queries and activities.
• Review and maintain essential study documentation, Investigator Files and TMF/e TMF.
• Support regulatory and ethics submissions by coordinating required documentation.
• Monitor study timelines, recruitment, site performance and key study metrics.
• Support the identification and follow-up of protocol deviations and other study issues.
• Prepare study documentation, visit reports and follow-up communications.
• Participate in Sponsor, Investigator and Monitor meetings as required.
• Complete all required training and maintain accurate study, time and expense records.
• Maintain confidentiality and ensure compliance with applicable regulations, SOPs and quality standards.

Requirements

• Degree in a scientific, life sciences or healthcare-related field.
• Initial experience in clinical research, ideally as a CTA, Clinical Trial Coordinator, Study Coordinator, Clinical Research Coordinator or similar.
• No prior CRA certification required – full training and development will be provided.
• Strong organisational, communication and interpersonal skills.
• Ability to manage priorities and work independently while receiving guidance from the Project Manager.
• Good knowledge of Microsoft Office.
• Good level of English.
• Willingness to travel for site visits as required
• Office based in Desio, Milan whilst conducting trainings

Career progression

This position provides a structured pathway from a non-certified CRA role to a certified CRA position following completion of the required training and certification.

What we offer

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

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.

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