Covance Sr Clin Res Assoc in Herzliya Pituah, Illinois
Covance is actively recruiting a Senior CRA in Israel.
This is a full time Client Dedicated role so the selected candidate will only be working on studies from a single sponsor!
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
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 reviewMonitor 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 Covance travel policy
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports
Manage small projects under direction of a Project Manager/Director as assigned
Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned
Review progress of projects and initiate appropriate actions to achieve target objectives
Organize and make presentations at Investigator Meetings
Participate in the development of protocols and Case Report Forms as assigned
Participate in writing clinical trial reports as assigned
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
Conduct, report and follow-up on Quality Control Visits (CQC) 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
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedComplete process of 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, e.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 assignedPerform other duties as assigned by management
Education / Qualifications
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure )
Valid Driver's License
5-6 years of clinical monitoring experience.
Thorough understanding about drug development process
Fluent in English, both written and verbal.
Thorough knowledge of ICH Guidelines and GCP.
Job Number 2018-26653
Job Category Hidden (54284)
Position Type Full-Time
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