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Job Details

Senior Clinical Research Associate - Home based, Germany

Company: Covance
Location:
Reference: 68246BR
Closing Date: 19 Jul 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Do you know Covance is one of the most stable, fastest growing global Contract Research Organization? For example, our Clinical Development teams have supported the development of one-third of all prescription medicines in the market today and of 47 out of the 50 best-selling oncology drugs.

Requirements:

Covance is currently looking for a Senior Clinical Reseatch Associate to be based in Germany as a home based employee. You would be working within our Flexible Solutions department dedicated to one sponsor/client.
A Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.

Requirements:

  • 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


USPs of SCRA role:

  • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit' targets
  • Join a stable team of CRAs across German and benefit from outstanding training and development, both initially and throughout your career
  • Joiin a company where people tend to stay for 6-10 years rather than 1-3!
  • Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.


Duty Highlights:

 

  • Responsible for all aspects of study site monitoring including routine monitoring and close-outof clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaisewith 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 materialsand 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 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 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
  • Perform other duties as assigned by management


Key words:

Clinical Research, CRA, SCRA, Clinical Research Associate, Clinical Team Lead, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical, Munich, Germany

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.


 

Apply for this job: Senior Clinical Research Associate - Home based, Germany

Contact Information:

Address:  Covance- Warsaw


Poland
Tel: 
Fax: 
Website:  Visit Our Web Site

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