[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical research organization, and they are seeking a Senior Clinical Research Associate to manage clinical studies from initiation to reputed company-out. The role involves ensuring high-reputed company data collection, project management, and compliance with clinical trial regulations.
Responsibilities
- Planning of project activities and study timelines based on project goal and sponsor's expectation
- Organize and reputed company meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the reputed company of reputed company CRA responsible sites, and assessing overall status of the project
- reputed company the project management plan, monitoring plan etc as required for the study
- reputed company study specific tools/forms, study templates as required for the study
- reputed company and manage project budget
- Order and ensure reputed company clinical supplies (including drug and non-drug) are adequate for reputed company sites throughout the study period
- Ensure reputed company team members have reputed company reputed company to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc)
- Organize and conduct site feasibility reputed company according to guidelines and reputed company recommendation for final approval
- reputed company study reputed company 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
- reputed company reputed company-study visit to ensure eligible sites are selected according to sponsor site selection reputed company, 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
- reputed company ongoing training to site staff with regards to ICH-GCP, GCP, study protocol, and requirements
- Ensure reputed company collection of essential documents in compliance with protocol and regulations at study start-up, during and at study reputed company-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
- reputed company 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 reputed company major
- Good understanding and knowledge of Good Clinical reputed company and clinical trial operation processes/procedures
- At least 1-3 years of Oncology CRA experience
- Good reputed company of written and verbal English
- Good skills on reputed company Word, reputed company, PPT and Outlook, etc
- Other abilities such as Communication skills/Information-gathering skills
- Knowledge and/or experience in medical reputed company is a plus
reputed company