If you are a highly motivated and experienced CRA looking for an opportunity to join a company that will identify and appreciate your potential, you are invited to send your CV to:
NovaTrials welcomes committed and trustworthy CRAs with excellent ability to work independently and assume responsibility of both explicitly and implicitly assigned tasks.
Purpose of Job:
Provides administrative support to the CRAs and project teams in accordance with ICH GCP, NovaTrials SOPs and local regulations. CTA Ensures clinical trial administration is performed such that the subjects’ rights, safety and wellbeing are protected and that the clinical trial data are reliable.
- Serves as a member of the project team with the goal to contribute towards efficient management of clinical trials
- Manages inventories for clinical trials supplies
- Assists the project team with preparation and shipment of Clinical Trial documentation
- Develops and maintains the study specific investigator database
- Serves as an office based point of contact for all sites during the course of the study
- Sets up and maintains the Trial Master File (TMF)
Purpose of Job:
Core monitoring role, with advanced responsibilities, critical and central to the conduct of the clinical project. The CRA oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
- To monitor the proper conduct, documentation and progress of the study
- Identify, select, and monitor performance of investigational sites for clinical studies
- Perform clinical data review of data listings and summary tables to assure the quality at site and the provision of clean data
- Ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate as appropriate
- Overall coordination of clinical trials from design to closeout and reporting.
- To be fully aware of the Sponsor’s Study requirements
- To be fully aware of ICH GCP and country regulatory requirements
Purpose of Job:
project managers are charged with oversight of all relevant functional areas involved in delivering NovaTrials services. Assigned projects may be global or national, and project managers may oversee multiple studies.
The PM will work closely with NovaTrials CEO and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory/QA etc. to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.
- Develop and maintain good working relationships with company clients as well as investigators and study staff
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
- Negotiate and manage the budget and payments for investigative sites, if applicable
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Oversee performance of third party vendors and field CRAs including co-monitoring
- Collaboration with major functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions and ensure the implementation of timely solutions
- Accountability for ensuring all project deliverables meet customers' expectations as well as NovaTrials standards
- Understanding scope of work, financial aspects of the project, expected project performance and strategies involved e.g. patient recruitment
- Attendance at Clinical Project Team set up meetings with the sponsor
- Attendance at Clinical Project Team routine meetings with the sponsor
- Being aware of communication channels per each assigned project for quick escalation of issues
- Planning the assignment of projects to CRAs based on clear understanding of their FTE status and pipeline projects