Description
We are seeking a Clinical Research Associate to manage and monitor clinical studies at various sites.
The successful candidate will be responsible for:
- Conducting routine monitoring and closeout of clinical sites
- Maintaining study files and conducting pre-study and initiation visits
- Liaising with vendors and ensuring the implementation of project plans
- Ensuring the protection of study patients by verifying informed consent procedures and protocol requirements
- Reviewing data for missing or implausible entries
- Ensuring audit readiness at the site level
- Preparing accurate and timely trip reports
- Interacting with internal work groups to evaluate needs, resources, and timelines
- Acting as a contact for clinical trial supplies and other suppliers
- Managing investigator site budgets
- Tracking and following up on Serious Adverse Event reporting
- Independently performing CRF review and query generation
- Assisting with training and development of new employees
- Coordinating designated clinical projects as a Local Project Coordinator
The ideal candidate will have:
- A university or college degree in a related allied health profession
- 1 year of experience in a clinical monitoring related role
- Basic knowledge of Regulatory Guidelines and the clinical trial process
- Fluent in local office language and in English
- Good planning, organisation, and problem-solving skills
- Valid Driver's License
Preferred qualifications include:
- Additional experience in a related field
- On-site monitoring experience
- Ability to maintain confidentiality of data and information
- Demonstrated ability to conduct clinical operations activities effectively and efficiently
- Understanding of medical and clinical research terminology and clinical research processes