Clinical Research Coordinator Senior
hace 3 días
We are seeking a highly skilled and motivated Clinical Research Coordinator Senior to join our team in a home-based role. This is an exciting opportunity for someone who is passionate about clinical research and wants to work in a dynamic and innovative environment.
Responsibilities- Manage and implement clinical studies, providing support to colleagues as needed
- Collect and review essential documents throughout the study lifecycle, including site activation
- Manage the electronic Trial Master File for each site, performing periodic QCs and site-level maintenance of the eTMF
- Update Clinical Management Systems, local regulatory tasks, protocol amendments, submissions packages preparations for sites/ethics committees submissions
- Conduct remote site monitoring visits and/or targeted on-site visits as needed
- Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks
- Perform study tracking CTMS
- Act as primary site contact/liaison for study and site management issues, including addressing questions, managing study supplies, and conducting offsite central monitoring visits and contacts (pre-study, initiation, monitoring, and close-out visits)
- Evaluate issues and risks, escalating them as necessary
- Provide training and mentoring to less experienced team members
- Support manager and interface with partner departments to enhance project delivery
- Bachelor's Degree, preferably in health/sciences
- In-depth knowledge of the drug development process
- +3 years' experience in a similar position
- Knowledge about ethics committees and MOH submissions for protocols, amendments, investigator brochure, and ICFs
- In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements
- Advanced English level (oral and written) - mandatory
- Monitoring/remote monitoring experience (recommended for level I - mandatory for senior)
- Good leadership skills, advanced critical thinking, and strong organization, communication, and time management skills
We offer a competitive salary, ranging from $60,000 to $80,000 per annum, depending on qualifications and experience. Additionally, you will enjoy various benefits, including:
- Annual leave entitlements
- A range of health insurance offerings to suit your needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the future
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
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