Clinical Research Associate
OPIS
Summary
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.
Job description
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
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
Benefits
- Competitive Salary
- Bonuses
- Professional Development Opportunities
Company overview
OPIS is a global clinical research organization (CRO) founded in 1998 by medical doctors from the pharmaceutical industry. With over 26 years of experience, OPIS provides comprehensive 360° clinical trial support spanning study concept creation, protocol development, full project execution, data management, and final study closure, analysis, and reporting. The company manages Phase I-IV clinical trials, including interventional, non-interventional, and medical device studies on an international scale. OPIS also conducts pre- and post-marketing clinical investigations for medical devices, diagnostic devices, nutraceuticals, and food supplements. The organization has successfully managed more than 1,500 studies across diverse therapeutic areas including oncology, cardiology, dermatology, endocrinology, gastroenterology, gene therapy, hematology, immunology, infectious diseases, and rare diseases. OPIS operates through a network of affiliates in 18 countries worldwide, leveraging specialized teams with deep therapeutic expertise and local regulatory knowledge to ensure high-quality project execution and scientific excellence in clinical development.