Clinical Trial Monitor II

3 weeks ago

Shanghai, Shanghai, China Fortrea Full time

Key Responsibilities

1) The following points outline the primary responsibilities of this role, which are not exhaustive.

2) Oversee all elements of clinical site monitoring, including routine site assessments and study closure activities, management of study documentation, execution of pre-study and initiation visits; collaborate with vendors; and additional tasks as directed.

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

4) General On-Site Monitoring Duties

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

6) Safeguard the welfare of study participants by confirming adherence to informed consent protocols and study requirements in accordance with relevant regulatory standards.

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

8) Monitor data for inconsistencies or missing information.

9) Ensure that the resources of the Sponsor and Fortrea are utilized efficiently by conducting required monitoring activities in a timely manner, following SOPs and established protocols, including managing travel expenses in line with Fortrea's travel policies.

10) Maintain audit readiness at the site level.

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

12) Prepare precise and prompt trip reports.

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

14) Conduct feasibility assessments as needed.

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

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 assigned by the supervisor.

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

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

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

20) Assist in the training of new staff, including 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.

Experience Requirements

Minimum Qualifications:


• A minimum of one year of clinical monitoring experience is preferred, or an equivalent combination of education and experience that enables 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 procedures.


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


• Ability to work with minimal supervision.


• Excellent communication and interpersonal skills.


• Strong analytical and negotiation abilities.


• Proficient in computer applications.


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


• Demonstrates efficiency and effectiveness in a matrix environment.

Education and Qualifications

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.


• Thorough understanding of monitoring procedures.


• Basic knowledge of the clinical trial process.


• Valid Driver's License.

Equal Opportunity Employer Statement:

Labcorp is committed to fostering diversity and inclusion in the workplace and does not tolerate any form of harassment or discrimination. 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), family or parental status, marital status, sexual orientation, gender identity, or any other legally protected characteristic. We encourage all qualified individuals to apply.

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

  • Clinical Research Associate II

    2 weeks ago

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

    Job SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a key member of our clinical operations team, you will be responsible for ensuring the integrity and quality of our clinical trials.Key ResponsibilitiesConduct routine...

  • Clinical Research Associate II

    1 week ago

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

    Job SummaryFortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and...

  • Clinical Trial Manager

    1 week ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Manager to join our team at Thermo Fisher Scientific. As a Clinical Trial Manager, you will be responsible for overseeing the clinical aspects of allocated studies, ensuring compliance with ICH GCP and project-specific requirements.Key ResponsibilitiesDevelop and implement clinical tools, such as...

  • Clinical Trials Lead

    3 weeks ago

    Shanghai, Shanghai, China Roche Full time

    Position Overview Job Summary: 1. The individual will engage in cross-functional project teams dedicated to clinical research initiatives that support the registration of Roche Diagnostic products developed globally. This includes clinical software, instrument platforms, assays, reagents, devices, instruments, systems, and biomarkers. The role...

  • Clinical Trial Coordinator

    2 weeks ago

    Shanghai, Shanghai, China IQVIA Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Coordinator to join our team at IQVIA in Shanghai. As a Clinical Trial Coordinator, you will play a critical role in the success of our clinical trials by ensuring the smooth execution of trial operations.Key ResponsibilitiesTrial and Site AdministrationTrack and report essential documentsEnsure...

  • Lead Clinical Site Monitor

    3 weeks ago

    Shanghai, Shanghai, 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...

  • Clinical Trials Manager

    2 weeks ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly experienced Clinical Trials Manager to lead our clinical operations team. As a key member of our organization, you will be responsible for managing a team of clinical staff and managers across several countries or a geographic area.Key ResponsibilitiesManage staff, including interviewing and selection, job description...

  • Clinical Trials Activation Specialist

    17 hours ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trials Activation Specialist to join our team at Thermo Fisher Scientific. As a Clinical Trials Activation Specialist, you will be responsible for preparing, reviewing, and coordinating country submissions in line with our global submission strategy.Key ResponsibilitiesPrepare, review,...

  • Clinical Monitoring Specialist

    17 hours ago

    Shanghai, Shanghai, China Fortrea Full time

    Job SummaryWe are seeking a highly skilled Clinical Monitoring Specialist to join our team at Fortrea. As a Clinical Monitoring Specialist, you will be responsible for monitoring study sites, ensuring compliance with regulatory requirements, and maintaining accurate records.Key ResponsibilitiesMonitor study sites to ensure compliance with regulatory...

  • Clinical Trials Specialist

    2 weeks ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Support the Preparation and Coordination of Country SubmissionsAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Trials Specialist, you'll play a critical role in supporting the preparation and coordination of country submissions in line with our global submission...

  • Clinical Research Associate

    3 weeks ago

    Shanghai, Shanghai, China MakroTech Full time

    Job SummaryMakroTech is seeking a highly skilled Clinical Research Associate to manage day-to-day clinical trial activities in Shanghai, China. The ideal candidate will ensure compliance with protocols and regulatory requirements, and have experience in clinical trials and monitoring.Key ResponsibilitiesManage daily clinical trial operations and ensure...

  • Clinical Research Associate

    2 weeks ago

    Shanghai, Shanghai, China MakroTech Full time

    Role OverviewMakroTech is seeking a highly skilled Clinical Research Associate to manage day-to-day clinical trial activities in Shanghai, China. The ideal candidate will ensure compliance with protocols and regulatory requirements, reviewing clinical trial protocols, and participating in the design and execution of clinical studies.Key...

  • Clinical Research Associate

    3 weeks ago

    Shanghai, Shanghai, China MakroTech Full time

    Job SummaryMakroTech is seeking a highly skilled Clinical Research Associate to join our team in Shanghai, China. The successful candidate will be responsible for managing day-to-day clinical trial activities, ensuring compliance with protocols and regulatory requirements.Key ResponsibilitiesManage daily clinical trial operations and ensure compliance with...

  • Clinical Research Associate

    1 week ago

    Shanghai, Shanghai, China MakroTech Full time

    Role OverviewMakroTech is seeking a highly skilled Clinical Research Associate to join our team in Shanghai, China. The successful candidate will be responsible for managing day-to-day clinical trial activities, ensuring compliance with protocols and regulatory requirements.Key ResponsibilitiesManage daily clinical trial operations and ensure compliance with...

  • Clinical Research Specialist

    3 weeks ago

    Shanghai, Shanghai, China Roche Full time

    Position Overview Job Summary: 1. The individual will engage in cross-functional project teams tasked with overseeing clinical research initiatives to facilitate Roche Diagnostic China’s product registration for offerings developed by the Roche Group globally, including clinical software, instrument platforms, assays, reagents, devices,...

  • Clinical Study Manager

    2 weeks ago

    Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time

    Job SummaryWe are seeking a highly skilled Clinical Study Manager to join our team at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch. As a Clinical Study Manager, you will be responsible for the day-to-day management of one or more clinical studies, ensuring that assigned studies are conducted in accordance with GCPs, Local regulations and...

  • Clinical Study Manager

    3 weeks ago

    Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time

    Job SummaryWe are seeking a highly skilled Clinical Study Manager to join our team at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch. The successful candidate will be responsible for the day-to-day management of one or more clinical studies, ensuring that assigned studies are conducted in accordance with Good Clinical Practices (GCPs), local...

  • Clinical Research Associate II

    3 weeks ago

    Shanghai, Shanghai, China Fortrea Full time

    Key Responsibilities 1) The following points are designed to outline the primary functions of the role and are not an exhaustive enumeration of all tasks, skills, and responsibilities. 2) Oversee all facets of clinical site monitoring, including routine site evaluations and study closure, management of study documentation, conducting pre-study and...

  • Clinical Trials Expert

    3 weeks ago

    Shanghai, Shanghai, China Citeline Full time

    About CitelineCiteline is a leading provider of data and intelligence on clinical trials, drug treatments, medical devices, and regulatory and commercial landscapes. Our customers rely on us to deliver vital advantage when making critical R&D and commercial decisions. We serve over 3000 of the world's leading pharmaceutical, contract research organizations...

  • Clinical Trial Coordinator

    3 weeks ago

    Shanghai, Shanghai, China SHG Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd. Full time

    Job Summary:The Regional Study Coordinator plays a critical role in the successful delivery of clinical studies in their designated region. As a key liaison between Global Project Management, Client Representatives, and other departments, this individual ensures seamless regional study operations and effective communication with stakeholders.Key...