Site Monitoring Specialist

4 weeks ago

Shanghai, Shanghai, China Fortrea Full time

Key Responsibilities

1) The following points are designed to outline the general responsibilities of the role and are not an exhaustive list of all tasks, skills, and duties.

2) Oversee all facets of clinical site monitoring, including routine assessments and closure of study sites, management of study documentation, conducting pre-study and initiation visits, coordinating with vendors, and additional responsibilities as assigned.

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

4) General Monitoring Duties on-Site.

5) Ensure that study personnel conducting the protocol have received 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 processes and protocol requirements in accordance with applicable regulatory standards.

7) Verify the accuracy of data submitted on Case Report Forms (CRFs) or other data collection tools through thorough review of source documents.

8) Monitor data for any missing or implausible entries.

9) Ensure that the resources of the Sponsor and Fortrea are utilized efficiently by performing the required monitoring tasks in a timely manner, following SOPs and established guidelines, including managing travel expenses according to Fortrea's travel policy.

10) Maintain audit readiness at the site level.

11) Travel, including air travel, may be necessary and is a fundamental aspect of the role.

12) Prepare accurate and prompt 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 the supervisor.

17) May be required to work in a client-facing capacity.

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

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 contact as assigned.

22) Perform other duties as assigned by management.

Required Experience

Minimum Qualifications:


• A minimum of one year of clinical monitoring experience is preferred, or an equivalent combination of education and experience that allows for successful performance of the key responsibilities of the role.


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


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


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


• Ability to work with minimal supervision.


• Excellent communication and interpersonal skills.


• Strong analytical and negotiation skills.


• Proficient in computer applications.


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


• Capable of working efficiently and effectively in a matrix environment.

Education/Qualifications/Certifications and Licenses

Minimum Required:


• 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.


• In-depth 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.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea is committed to diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For more information about our data collection and storage practices, please refer to our privacy policy.

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