Discover new opportunities to grow your career as a Covance FSP by Labcorp Senior Clinical Research Associate.
Covance by Labcorp FSP are looking to hire a Senior CRA in Hungary. In this position you will be fully dedicated to our sponsor and will be home based.
At Covance by Labcorp, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance by Labcorp employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance by Labcorp has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance by Labcorp studies.
With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.
- Own all aspects of site management as described in the project plans
- Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
- Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries
- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
- Review progress of projects and initiate appropriate actions to achieve target objectives
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial suppliers and other vendors as assigned
- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform CRF reviews
- Generate queries and resolve issues according to data review guidelines on Covance by Labcorp or sponsor data management systems
- Assist with training, mentoring and development of new employees, e.g. co-monitoring
- University degree in life sciences (preferrably in pharmacy), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- Previous substantial experience in monitoring study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines preferrably in oncology studies
- Excellent understanding of Serious Adverse Event (SAE) reporting
- Ability to resolve project-related problems and prioritize workload for self and team
- You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
- Fluency in Hungarian both spoken and written - and good command of English is a must
Apply on company website