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Clinical Research Associate
1 month ago
Job Title: Clinical Research Associate - Study Site Monitoring
About UsHAN Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Hangzhou Branch is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience.
Compensation PackageWe offer a competitive salary package, estimated at ¥250,000 - ¥350,000 per annum, depending on experience and qualifications.
Job DescriptionThis role will be responsible for all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaison with vendors; and other duties as assigned.
The successful candidate will have six (6) months' experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.), a basic understanding of Regulatory Guidelines, and the ability to work within a project team. A university or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), is also required.
The ideal candidate will possess good planning, organization and problem-solving skills, as well as good computer skills with a working knowledge of a range of computer packages. They will also be able to work efficiently and effectively in a matrix environment, and demonstrate a basic understanding of the clinical trial process.
In this role, you will ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study, and verify that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
You will also monitor data for missing or implausible data, ensure audit readiness at the site level, and prepare accurate and timely trip reports. Additionally, you will interact with internal work groups to evaluate needs, resources and timelines, and act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Responsibilities may also include undertaking feasibility work when requested, participating in and following-up on Quality Control Visits (QC) when requested, recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
The role requires fluency in English, both written and verbal, and the ability to travel, including air travel, which is an essential function of the job.
RequirementsThe successful candidate will have:
- Six (6) months' experience in a related role
- A basic understanding of Regulatory Guidelines
- The ability to work within a project team
- Good planning, organization and problem-solving skills
- Good computer skills with a working knowledge of a range of computer packages
- Able to work efficiently and effectively in a matrix environment
- A basic understanding of the clinical trial process
We are seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Please note that we do not discriminate based on age, disability, gender, marital status, national origin, race, religion, sexual orientation or any other protected characteristic.
