Site Monitoring Specialist I/II

2 months ago

Chengdu, Sichuan, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

Position Overview

I. Key Responsibilities:

1) The following points outline the primary functions of this role, not intended to be an exhaustive list of all tasks, skills, and responsibilities.

2) Oversee all facets of clinical site monitoring, including routine evaluations and closure of study sites, management of study documentation, conducting pre-study and initiation visits; collaborate with vendors; and perform additional duties as assigned.

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

4) General Responsibilities for On-Site Monitoring.

5) Ensure that study personnel are equipped with the necessary materials and instructions to safely enroll participants in the study.

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

7) Validate the accuracy of data submitted on Case Report Forms (CRFs) or other data collection instruments through meticulous source document examination.

8) Monitor data for any missing or implausible entries.

9) Ensure the judicious use of resources by executing required monitoring tasks efficiently, in line with Standard Operating Procedures (SOPs) and established guidelines, including managing travel expenditures in a cost-effective manner.

10) Maintain audit readiness at the site level.

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

12) Generate accurate and timely trip reports.

13) Oversee all aspects of registry management as outlined in the project plans.

14) Conduct feasibility assessments when requested.

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

16) Assist 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 capacity.

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

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

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

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

22) Perform additional duties as assigned by management.

II. Required Experience:

Minimum Qualifications:

• At least 1 year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to effectively fulfill the key responsibilities of the role.

• Proficient in independently monitoring study sites in accordance with protocol monitoring guidelines, SOPs, and local regulatory standards.

• Comprehensive understanding of Serious Adverse Event (SAE) reporting, including the generation of reports, narratives, and follow-up actions.

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

• Ability to work with minimal supervision.

• Excellent communication and interpersonal abilities.

• Strong analytical and negotiation skills.

• Proficient in computer applications.

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

• Works efficiently and effectively in a matrix environment.

III. Education/Qualifications/Certifications and Licenses:

Minimum Requirements:

• A university or college degree, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure). Equivalent experience may be considered.

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

• In-depth knowledge of monitoring procedures.

• Basic understanding of the clinical trial process.

• Valid Driver's License.

Fortrea is dedicated to attracting motivated problem-solvers and innovative thinkers who share our commitment to overcoming challenges in clinical trials. Our steadfast goal is to transform the development process, ensuring the rapid delivery of life-altering ideas and therapies to patients in need. Join our outstanding team and enjoy a collaborative environment that fosters personal growth, enabling you to make a significant global impact.

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