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Clinical Trial Coordinator
2 semanas atrás
Overview
Clinical Research Associates (CRAs) at Pharmaceutical Research Associates, Inc. play a vital role in the success of our clinical trials. As a CRA, you will be responsible for coordinating all aspects of clinical monitoring and site management. Your expertise will ensure that our studies are conducted in accordance with regulatory guidelines and local regulations.
Responsibilities
- Qualify potential investigative sites, initiate clinical trials, and maintain study files.
- Verify the protection of study participants by confirming informed consent procedures and protocol adherence.
- Manage the integrity of clinical data and ensure compliance with approved protocols, GCP, and applicable regulations.
- Facilitate trial deliverables, such as subject enrollment and data submission.
- Properly manage and account for Investigational Product (IP).
Required Skills and Qualifications
- 3 years of experience supporting clinical trials, including 2 years of on-site monitoring experience principally in Oncology.
- In-depth knowledge of the drug development process and ICH-GCP.
- Sound knowledge of applicable policies and procedures, SOPs, work instructions, and guidance documents.
- Good communication, collaboration, and time management skills.
Benefits
- Variety of annual leave entitlements.
- A range of health insurance offerings to suit individual needs.
- Competitive retirement planning opportunities.
- Global Employee Assistance Programme for mental well-being.
- Lifetime assurance and flexible country-specific benefits.