Covance Senior CRA in Munich, Delaware

Job Overview

Covance is currently looking for a SCRA to be based in Germany as a home based employee. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

Education / Qualifications

Degree in Sciences or equivalent experience in role

Experience

  • Ensure the protection of study patients by verifying that informed consentproceduresand 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 of document review

  • Monitor data for missing or implausible data

  • Ensure the resources of the Sponsor and Covance are spent wisely by performing 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 and 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 toregulatory authorities, translation of study-related documentation, organization of meetings andother tasks as instructed by supervisor as assigned

  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

  • Complete 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 assigned

  • Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

  • Excellent understanding of Serious Adverse Event reporting

  • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Germany.

  • Previous experience of leading/managing a CRA team

  • Experience of reviewing CRA trip reports

  • Fluency in speaking and writing both English and German

  • Oncology experience

  • Degree in life sciences OR equivalent experience in clinical monitoring

  • Profound experience in clinical monitoring, oncology experience preferred

Job Number 2018-18904

Job Category Clinical Research Associate

Position Type Full-Time

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