Covance

Senior Clinical Research Associate

DE-Munich
Job Number
2017-14581
Job Category
Clinical Research Associate
Position Type
Full-Time

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

Life science degree

Experience

  • 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 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
  • At least 3-4 years experience in clinical monitoring, oncology experience preferred

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