ClinChoice is seeking a Senior Clinical Research Associate (Senior CRA) to join their in-house team. The Senior CRA will work on 2-3 clinical trials and will be responsible for site management, both on-site and remotely. The role involves working on projects from a varied client base. Previous experience monitoring oncology and/or respiratory clinical trials is required.
The role involves:
- Keeping up to date with all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
- Assisting in the selection of sites, site evaluation visits, initiation visits and ensure follow-up.
- Training site staff in all study procedures.
- Conducting periodic monitoring visits, including completion of monitoring visit reports.
- Reviewing the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
- Conducting source data verification and in-house review of clinical data.
- Managing the investigational products and the trial material.
- Cooperating with the site staff to ensure proper reporting from the site for safety issues.
- Conducting and reporting study termination and related activities.
- Acting as the main contact person for the site.
- Providing general support to the Clinical Research Division on quality control of clinical data.
- Addressing any issues that can jeopardise the conduct of the clinical projects assigned.
Requirements:
- University Degree in scientific, medical or paramedical disciplines.
- Proven experience as a CRA, performing on-site monitoring activities.
- Experience with oncology or respiratory trials is required.
- Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Fluent in English and local language(s).
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
- Willingness to travel.
ClinChoice Offers:
- A quality-focused, collaborative “one-team” culture.
- Professional development.
- Excellent work-life balance.
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ClinChoice
ClinChoice is a global, full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience, ClinChoice focuses on delivering high-quality results through its team of over 4,000 professionals across the Americas, Europe, and Asia-Pacific. The company emphasizes employee development and maintains a supportive culture, driven by a mission to accelerate the development of innovative drugs and devices for a healthier world.