
Clinical Trial Specialist
2 weeks ago
We are seeking a highly skilled and experienced Research Associate II to join our team. The successful candidate will be responsible for coordinating clinical trials, monitoring activities, and ensuring compliance with regulatory requirements.
About the JobThe Research Associate II is a member of the Clinical Operations group, responsible for site management, monitoring tasks, and operational support of clinical trials. The group allocates resources to projects as appropriate to assist with implementing project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).
- Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
- Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
- Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
- Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
- Prepare, plan, organize, and conduct site initiation visits.
- Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
- Tertiary qualifications in a related science or health care discipline.
- Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 3 – 5 experiences in monitoring and site management experience is mandatory.
- Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
We understand that great work happens when people feel valued and supported. That's why we provide:
- Competitive compensation packages to reflect your skills and experience.
- Flexibility to enjoy hybrid or remote working arrangements, depending on your location and role.
- Career growth opportunities through access to learning programs and a global network of scientific leaders.
- Employee wellbeing initiatives to promote work-life balance, health, and team connection.
- Global opportunities to work on diverse projects and clients.
This role is not applicable to seniority levels.
Employment typeThis role is classified as other employment types.
Job functionThis role falls under the job functions of research, analyst, and information technology.
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