Clinical Research Associate

Role Overview

The Clinical Research Associate position entails overseeing the execution and monitoring of clinical trials to ensure strict adherence to study protocols, International Council for Harmonisation Good Clinical Practice (ICH-GCP), and relevant regulations. Responsibilities encompass site selection, initiation, routine monitoring, and final close-out procedures, prioritizing data integrity and patient safety. Reporting is to the Clinical Project Manager.

Key Responsibilities

• Identify, evaluate, and initiate investigational sites for clinical trials.
• Conduct feasibility assessments, pre-study visits, initiation sessions, monitoring visits, and site close-out activities effectively.
• Ensure compliance with study protocols, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and regulatory standards.
• Perform source data verification to maintain accuracy and completeness of trial data.
• Oversee patient recruitment progress and assist sites to achieve enrollment targets.
• Ensure thorough reporting of adverse events and deviations from the protocol.
• Manage investigational product handling, including storage and accountability requirements.
• Maintain study documentation such as Trial Master File (TMF), electronic TMF, and Investigator Files.
• Prepare detailed monitoring reports and follow up on necessary communications.
• Collaborate closely with project teams, sponsors, and site personnel to facilitate smooth trial operations.
• Support audit and inspection readiness and contribute to mentoring junior CRAs.

Candidate Requirements

• Possess a degree in a relevant scientific field.
• Have at least two years of experience as a Clinical Research Associate or in clinical trial monitoring.
• Demonstrate strong knowledge of ICH-GCP, ISO 14155 standards, and clinical trial processes.
• Proficient in English and skilled in Microsoft Office applications.
• Exhibit excellent organizational, communication, and problem-solving skills.
• Capable of working independently as well as collaboratively within a team.

Compensation and Benefits

The company offers a competitive remuneration package along with additional benefits and bonuses. Opportunities for professional growth exist within this expanding organization.

About OPIS

Established in 1998 in Italy and now operating internationally, OPIS is a science-driven biotechnology Contract Research Organization (CRO) specializing in high-quality management of multi-national clinical trials. We provide advanced IT solutions and innovative strategies to manage the increasing complexity of clinical projects. Our experienced professionals support clients across diverse domains including medical writing, scientific and statistical consultancy for trial design, regulatory affairs, pharmacovigilance, and beyond, contributing significantly to client achievements.

Data Privacy Notice

Candidates are encouraged to review the information notice regarding personal data processing available on the company’s website.