Clinical Research Associate

Opis S.r.l.; Northern (KY); On-site; USD 60,000 - 90,000; Full time

Job summary

OPIS is seeking a Clinical Research Associate to manage and monitor clinical trials, ensuring adherence to protocols, ICH-GCP, and applicable regulations across multi-country projects. You will conduct site qualification, initiation, monitoring, and close-out visits, while safeguarding data quality and patient safety.

The role reports to the Clinical Project Manager and requires a scientific degree, 2+ years' CRA experience, strong regulatory knowledge, and solid English and MS Office skills.

Qualifications

• 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.

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.

Skills

ICH-GCP

English proficiency

Office suite

Strong organization

Teamwork

Education

Degree in a scientific field

Tools

Microsoft Office

Job description

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.