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CPS(Contract Personal Service- Dedicated CRA) is looking for a The responsibilities of the CL are to oversee the clinical site management aspect of designated projects at a local or international level in accordance with CLIENT/PAREXEL SOPs. As CL responsibilities will include managing clinical monitoring activities and liaising with project management and the sponsor (if appropriate) to ensure that the clinical deliverables are met. Responsibilities will also include some on site monitoring/co-monitoring to ensure familiarity with the protocol and the opportunity to identify areas that may require additional training.
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
As CL manage the clinical team to ensure that the clinical deliverables are met.
Function as mentor and role model for other CRA team members to ensure study specific training for CRAs and that the sites are effectively managed.
Building and maintaining good and effective relationships with study sites for PAREXEL
Perform co-monitoring visits with less experienced CRAs or at problem sites, as required, to identify possible areas for training and address these with the local training manager where applicable.
Identify and qualify potential investigators to ensure that the sites have adequate time and can fulfil their obligation to the study.
If appropriate, collect investigator site regulatory documents and perform Quality Check prior to submission to EC, Regulatory Authority and SRP review.
Track the flow of regulatory documents for all projects responsible for in order to co-ordinate and deliver the appropriate regulatory documents to meet regulatory and ethics committee submission dates.
Initiate investigational sites to ensure that they have a thorough understanding of the clinical protocol and that they understand their obligations to conduct a clinical trial as required by applicable regulations.
Ensure that the site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines.
Ensure that the site personnel are adhering to the protocol and address any issues concerning protocol non-compliance with the principal investigator.
Provide ongoing training to the site personnel with regards to ICH-GCP guidelines and PAREXEL/CLIENT SOPs to ensure the quality and integrity of the data.
Acting as CL prepares and provide study specific tools, site-level documents (site recruitment plan), ensure the review and changes maintaining.
Ensure the effective and timely co-ordination of the supply (and subsequent disposal) of clinical materials to the site to ensure that the site can start to actively recruit patients as soon as ethical approval at the site has been granted.
Collaborate with other departments (e.g. Medical, Regulatory) to ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods.
Perform site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues to be escalated to the CL, Project Manager or Manager, Clinical Operations, as appropriate.
Prepare and submit visit reports in a timely manner (Per PXL SOPs or contract as appropriate).
Review reports generated by other CRAs assigned to the project in the region. Highlight common issues and address these with the team as a training need. Raise concerns with the Project Manager/ CL or Manager, Clinical Operations, as appropriate.
As Clinical Lead, manage and monitor time budgeting, incorporating revenue recognition, to ensure that any potential cost over-runs are identified and addressed at an early stage.
Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete, met quality requirements and can be used as a source of reference.
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