Clinical Research Associate

Role overview

The Clinical Research Associate will oversee the running and tracking of clinical studies to make sure they follow the approved protocol, ICH-GCP standards, and all relevant regulations. The position covers site identification, study start-up, monitoring, and close-out, with a strong focus on data integrity and participant safety. This role reports to the Clinical Project Manager.

Core responsibilities

• Assess potential investigational sites, select suitable locations, and support site activation.
• Carry out feasibility reviews, pre-study assessments, site initiation, routine monitoring, and close-out visits.
• Verify that trial conduct aligns with protocols, SOPs, ICH-GCP, and applicable regulatory obligations.
• Check source records to confirm that study data is complete, accurate, and traceable.
• Track enrollment progress and help sites stay on course with recruitment goals.
• Review and escalate adverse events and protocol deviations as required.
• Oversee investigational product receipt, storage, use, and accountability.
• Keep essential trial documentation current, including TMF/eTMF and Investigator Files.
• Prepare monitoring visit reports and related follow-up correspondence.
• Work closely with sponsors, project teams, and site personnel to keep studies on track.
• Assist with audits and inspections, and provide guidance to junior CRAs when needed.

Candidate profile

• A degree in a scientific discipline is required.
• At least 2 years of experience in CRA work or clinical trial monitoring is expected.
• Working knowledge of ICH-GCP, ISO14155, and general clinical trial operations is essential.
• Strong command of English and confidence using Microsoft Office are needed.
• Excellent organization, communication, and problem-solving skills are important.
• The role suits someone who can work both independently and collaboratively.

About OPIS

OPIS began in Italy in 1998 and has grown into an international, science-led biotech CRO. The company delivers end-to-end trial management for multi-country studies, supported by advanced technology and modern approaches to complex projects. Its strength comes from a highly specialized team with deep expertise across clinical trial management, medical writing, scientific and statistical consultancy for study design, regulatory support, pharmacovigilance, and more.

Compensation and benefits

A competitive salary is offered, along with additional benefits and bonuses. The company also provides an opportunity to build and advance your professional career within a growing organization.

Additional information

Please review the data processing information notice available in the candidates information section of the company website.