Clinical Research Associate

3 weeks ago

Guangzhou, Guangdong, China SGA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Guangzhou Branch Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

Key Responsibilities:

1. Conduct routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned.

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

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

4. Monitor data for missing or implausible data and ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

5. Ensure the resources of the Sponsor and Labcorp Drug Development 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 Labcorp Drug Development travel policy.

Requirements:

1. A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.

2. Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines.

3. Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

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

5. Ability to work with minimal supervision.

6. Good communication and interpersonal skills.

7. Good analytical and negotiation skills.

8. Computer competency.

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

10. Works efficiently and effectively in a matrix environment.

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. Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.

3. Thorough knowledge of monitoring procedures.

4. Basic understanding of the clinical trial process.

5. Valid Driver's License.

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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