At least 2 years of CRA or clinical trial monitoring experience is required.
Strong knowledge of ICH-GCP, ISO 14155, and clinical trial processes is required.
Good English and Microsoft Office skills are required.
Strong organizational, communication, and problem-solving abilities are required.
Ability to work independently and as part of a team is required.
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, including TMF/eTMF and Investigator Files.
Write monitoring reports and follow-up communications.
Collaborate with project teams, sponsors, and site staff.
Support audits and inspections, and mentor junior CRAs.
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.
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.
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