Clinical Research Associate

4 weeks ago

Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

As a Clinical Research Associate at Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch, you 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, and liaison with vendors. You will also be responsible for all aspects of site management as prescribed in the project plans.

Key Responsibilities:

1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

4. Monitor data for missing or implausible data.

5. Ensure the resources of the Sponsor and Company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Company travel policy.

6. Ensure audit readiness at the site level.

7. Travel, including air travel, may be required and is an essential function of the job.

8. Prepare accurate and timely trip reports.

9. Interact with internal work groups to evaluate needs, resources, and timelines.

10. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.

Requirements:

1. Six (6) months experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.).

2. Basic understanding of Regulatory Guidelines.

3. Ability to work within a project team.

4. Good planning, organization, and problem-solving skills.

5. Good computer skills with good working knowledge of a range of computer packages.

6. Works efficiently and effectively in a matrix environment.

7. Valid Driver's License.

Education/Qualifications/Certifications and Licenses:

1. University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

2. Basic knowledge of Regulatory Guidelines.

3. Basic understanding of the clinical trial process.

4. Fluent in local office language and in English, both written and verbal.

Fortrea is actively 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.

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