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Clinical Monitoring Specialist
2 months ago
As a Clinical Monitoring Specialist at BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors. You will also be responsible for site management as prescribed in the project plans.
Key Responsibilities:
1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
4. Monitor data for missing or implausible data.
5. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
6. Ensure audit readiness at the site level.
7. Travel, including air travel, may be required and is an essential function of the job.
8. Prepare accurate and timely trip reports.
9. Manage small projects under direction of a Project Manager/Director as assigned.
10. Review progress of projects and initiate appropriate actions to achieve target objectives.
11. Organize and make presentations at Investigator Meetings.
12. Participate in the development of protocols and Case Report Forms as assigned.
13. Participate in writing clinical trial reports as assigned.
14. Interact with internal work groups to evaluate needs, resources, and timelines.
15. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
16. Responsible for all aspects of registry management as prescribed in the project plans.
17. Undertake feasibility work when requested.
18. Conduct, report, and follow-up on Quality Control (QC) visits when requested.
19. Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor as assigned.
20. Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
21. Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.
Requirements:
1. Two (2) years of Clinical Monitoring experience.
2. Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.
3. Advanced site monitoring skills.
4. Advanced study site management skills.
5. Advanced registry administration skills.
6. Ability to work with minimal supervision.
7. Good planning and organization skills.
8. Good computer skills with good working knowledge of a range of computer packages.
9. Advanced verbal and written communication skills.
10. Ability to train and supervise junior staff.
11. Ability to resolve project-related problems and prioritize workload for self and team.
12. Ability to work within a project team.
13. Works efficiently and effectively in a matrix environment.
