Clinical Research Associate

OPIS; United States; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Job summary

OPIS is seeking a Clinical Research Associate to manage and monitor international multicenter trials in compliance with ICH-GCP and ISO14155. The role covers site identification, initiation, monitoring, and close-out, with focus on data quality and patient safety.

The CRA will report to the Clinical Project Manager and work with sponsors, sites, and project teams to ensure timely, accurate trial execution and thorough documentation across TMF/eTMF systems.

Qualifications

• Degree in a scientific field is required.
• Minimum 2 years’ CRA or clinical trial monitoring experience.
• Strong knowledge of ICH-GCP and ISO14155 and 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 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 knowledge

English language proficiency

Organizational skills

Communication skills

Education

Bachelor's 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.

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.