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Job Overview:Clinical Research AssociateNon-OncologyLabcorp Drug Development is seeking a CRA to be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned and to be responsible for all aspects of site management as prescribed in the project plans.General On-Site Monitoring Responsibilities:Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of 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 data
Ensure the resources of the sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy
Ensure audit readiness at the site level
Travel, including air travel, may be required and is an essential function of the
Prepare accurate and timely trip reports
Interact with internal work groups to evaluate needs, resources and timelines
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Participate in and follow-up on Quality Control Visits (QC) when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
Assist Senior CRA with managing investigator site budgets
Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
Assist with training, mentoring and development of new employees, g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management
Education/Qualifications:Minimum Required:Must have a Bachelor's Degree (or equivalent) with 2 - 4 years of relevant healthcare experience in the pharmaceutical industry or clinical research, including
Fluent in local office language and in English, both written and verbal
COVID-19 vaccination required
Experience:Minimum Required:1 - 2 years of monitoring and site management experience
Basic understanding of Regulatory Guidelines
Ability to work within a project team
Good planning, organization and problem solving skills
Good computer skills with good working knowledge of a range of computer packages
Works efficiently and effectively in a matrix environment
Valid Driver's License
