Note: The job is a remote job and is open to candidates in USA. Tigermed is a clinical research organization seeking a Clinical Research Associate to manage clinical studies from site selection to close-out. The role involves ensuring data quality, project management, and compliance with regulations while leading site activities and training staff.
Responsibilities
- Planning of project activities and study timelines based on project goal and sponsor's expectation
- Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project
- Develop the project management plan, monitoring plan etc as required for the study
- Develop study specific tools/forms, study templates as required for the study
- Develop and manage project budget
- Order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period
- Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc)
- Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval
- Track study progress and ensure project is conducted according to the plan
- Communicate to monitors new study information, study timelines and goals, study requirements. Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management)
- Submit the weekly project report to management (e.g. Project Director, Senior Management)
- Study site selection, initiation (SIV) and clinical monitoring
- Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience
- Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations
- Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol, and requirements
- Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files
- Finalize budget and obtain signed contract from site, prior to site initiation visit
- Provide guidance and training to entry-level CRA/CRA I/CRA II in collaboration with Line Manager
Skills
- Bachelor degree or above in Medical, Pharmacology or Biology related major
- Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures
- At least 1-3 years of CRA experiences
- Good command of written and verbal English
- Good skills on Microsoft Word, Excel, PPT and Outlook, etc
- Other abilities such as Communication skills/Information-gathering skills
- Knowledge and/or experience in medical practice is a plus
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