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.
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
- 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
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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