6 maanden geleden
- Developing clinical study protocols, Phase I - III
- Monitoring data - remotely, on-site, and via other modes - focusing on data integrity and patient safety, in accordance with individual country regulations
- Creating and writing trial protocols
- Training site staff on therapy areas, protocol requirements, source documentation, and case report form completion.
-Planning day-to-day activities for study monitoring and setting priorities by the site.
-Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
-Liaise with ethics committee regarding rights, safety, and well-being of trial subjects.
-Experience working with CROs and other third-party vendors during the course of clinical trial planning and execution
-Ordering, tracking, and managing IP and trial materials.
-Overseeing and documenting IP dispensing, inventory, and reconciliation.
-Gauging the quality of clinical deliverables and addressing quality issues with team members.
-Managing query resolution with study sites and data management operations.
-Maintaining the project tracking system of subjects and site information.
-Participating in Investigators' Meetings as assigned by Project Managers.
-Maintaining contact with investigator sites via telephone calls between visits.
-Ensuring adherence to study timelines and budgets.
-Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
-Ensuring compliance with SOPs and local regulations, ICH, and GCP guidelines.
-Bachelor's Degree or above required in a life science or healthcare discipline.
-5-10 years of experience in clinical operation.
-Three (3) or more years of experience as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
-Oncology or autoimmune disease experience.
- Right to work in the US