Study Site Oversight Specialist

2 months ago

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

Company Overview:

BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd is a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a diverse array of clinical development, patient access, and technological solutions across numerous therapeutic domains. With a workforce exceeding 19,000 professionals operating in over 90 countries, we are at the forefront of transforming drug and device development for our partners and patients worldwide.

Key Responsibilities:

1) The following responsibilities outline the essential functions of the role, though they are not exhaustive.

2) Oversee all elements of study site monitoring, including routine assessments and the finalization of clinical sites, management of study documentation, execution of pre-study and initiation visits, coordination with vendors, and additional tasks as required.

3) Manage all aspects of site administration as outlined in project specifications.

4) On-Site Monitoring Duties:

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

6) Safeguard the rights of study participants by confirming adherence to informed consent protocols and regulatory requirements.

7) Verify 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 discrepancies or implausible entries.

9) Optimize the use of resources from both the Sponsor and BEJ Fortrea by executing monitoring tasks efficiently, in accordance with standard operating procedures (SOPs) and established guidelines, including prudent management of travel expenses.

10) Maintain audit readiness at the site level.

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

12) Prepare comprehensive and timely trip reports.

13) Manage smaller projects under the guidance of a Project Manager/Director as assigned.

14) Assess project progress and initiate appropriate actions to meet target objectives.

15) Organize and deliver presentations at Investigator Meetings.

16) Contribute to the development of protocols and Case Report Forms as needed.

17) Assist in drafting clinical trial reports as required.

18) Collaborate with internal teams to assess needs, resources, and timelines.

19) Serve as the point of contact for clinical trial supplies and other vendors as assigned.

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

21) Conduct feasibility assessments when requested.

22) Execute, document, and follow up on Quality Control (QC) visits as necessary.

23) 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.

24) Negotiate study budgets with prospective investigators and assist the legal department with agreements as needed.

25) Monitor and follow up on Serious Adverse Event (SAE) reporting, including the production of reports and narratives.

26) Independently conduct CRF reviews, generate queries, and resolve issues based on established data review guidelines.

27) Assist in the training, mentoring, and development of new staff members.

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

29) Perform additional duties as assigned by management.

Qualifications:


• Minimum of two (2) years of experience in Clinical Monitoring.


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


• Proficient site monitoring skills.


• Strong study site management capabilities.


• Advanced registry administration skills.


• Ability to work independently with minimal supervision.


• Excellent planning and organizational skills.


• Proficient computer skills with a solid understanding of various software applications.


• Exceptional verbal and written communication abilities.


• Capability to train and supervise junior staff members.


• Strong problem-solving skills and ability to prioritize workload effectively.


• Experience working within a project team.


• Demonstrated efficiency and effectiveness in a matrix environment.

BEJ Fortrea is actively seeking dedicated problem-solvers and innovative thinkers who share our commitment to advancing clinical trials. Our mission is to enhance the development process, ensuring the rapid delivery of transformative therapies to patients in need. Join our dynamic team and experience a collaborative environment that fosters personal growth and enables you to make a significant global impact.

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