Clinical Research Associate II

1 month ago

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

As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch offers pharmaceutical, biotechnology, and medical device clients a comprehensive array of clinical development, patient access, and technological solutions across over 20 therapeutic areas. With a workforce exceeding 19,000 professionals operating in more than 90 countries, SHA Fortrea is reshaping the landscape of drug and device development for partners and patients worldwide.

Key Responsibilities:

1) The following responsibilities outline the general scope of the position and are not exhaustive of all tasks, skills, and duties.

2) Oversee all facets of study site monitoring, including routine assessments and closure of clinical sites, maintenance of study documentation, execution of pre-study and initiation visits; collaborate with vendors; and undertake additional responsibilities as assigned.

3) Manage all aspects of site operations as defined in the project plans.

4) General On-Site Monitoring Duties.

5) Ensure that study personnel have received the necessary materials and instructions to safely enroll patients in the study.

6) Safeguard the rights of study participants by confirming adherence to informed consent procedures and protocol requirements in accordance with applicable regulatory standards.

7) Validate the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools through meticulous source document review.

8) Monitor data for any missing or implausible entries.

9) Ensure the judicious use of resources from the Sponsor and SHA Fortrea Drug Development by executing required monitoring tasks efficiently, following SOPs and established guidelines, including managing travel expenses in a cost-effective manner according to company travel policies.

10) Maintain audit readiness at the site level.

11) Travel, including air travel, is a necessary component of this role.

12) Prepare accurate and timely trip reports.

13) Manage all aspects of registry operations as outlined in the project plans.

14) Conduct feasibility assessments when requested.

15) Participate in and follow up on Quality Control Visits (QC) as needed.

16) Engage in the recruitment of potential investigators, preparation of ethics committee submissions, notifications to regulatory bodies, translation of study-related documents, organization of meetings, and other tasks as directed by supervisors.

17) May be required to operate in a client-facing environment.

18) Track and follow up on Serious Adverse Event (SAE) reporting, manage the production of reports, narratives, and follow-up on SAEs.

19) Independently conduct CRF reviews; generate and resolve queries based on established data review guidelines on SHA Fortrea Drug Development or client data management systems as assigned by management.

20) Assist in the training of new employees, such as co-monitoring.

21) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may serve as a local client contact as assigned.

22) Perform other duties as assigned by management.

Qualifications:

Experience:

• 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.

• Ability to independently monitor study sites in accordance with protocol monitoring guidelines, SOP, and local regulatory standards.

• Comprehensive understanding of Serious Adverse Event (SAE) reporting, report production, narratives, and follow-up processes.

• Strong planning, organizational, and problem-solving skills.

• Capability to work with minimal supervision.

• Excellent communication and interpersonal skills.

• Strong analytical and negotiation abilities.

• Proficient computer skills.

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

• Ability to work efficiently and effectively in a matrix environment.

Education/Qualifications/Certifications and Licenses:

• 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.

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

• Comprehensive knowledge of monitoring procedures.

• Basic understanding of the clinical trial process.

• Valid Driver's License.

SHA Fortrea is actively seeking motivated problem-solvers and innovative thinkers who share our commitment to overcoming challenges in clinical trials. Our unwavering dedication is to transform the development process, ensuring the swift delivery of life-changing therapies to patients in need.

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