
Senior Clinical Research Professional
Há 3 dias
Are you a detail-oriented and organized professional looking for a new challenge in clinical research?
Clinical Research Associate (CRA) RoleAbout the JobThe role of Clinical Research Associate is a critical component of our team, responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices.
- We are seeking a highly skilled CRA to conduct thorough on-site and remote monitoring of clinical research studies, reviewing study protocols, informed consent forms, and case report forms to ensure compliance with clinical practices.
- This individual will develop and implement tools, procedures, and processes to ensure quality monitoring, including creating monitoring plans, checklists, and templates.
- Our ideal candidate will contribute to the design, implementation, and delivery of processes, programs, and policies, participating in the development of standard operating procedures (SOPs) and training materials.
- They will manage defined components of projects or processes within their area of responsibility, coordinating site visits, tracking study progress, and resolving issues.
- Accurate and timely documentation of monitoring activities and findings is essential, including writing monitoring reports, follow-up letters, and action plans.
- Quality Assurance: Conduct regular site audits to ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Monitoring Plan Development: Develop and implement comprehensive monitoring plans to ensure efficient and effective monitoring of clinical trials.
- Training and Support: Provide training and support to investigators, site staff, and other stakeholders to ensure smooth study conduct.
- Documentation: Maintain accurate and up-to-date records of monitoring activities, including study start-up, initiation, and close-out visits.
- Bachelor's degree in a related field or equivalent experience.
- Minimum of 2-4 years of experience in clinical research monitoring.
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work independently and manage multiple priorities.
Let's Work Together to Advance Clinical Research
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