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Job Details

Senior Clinical Research Associate

Company: Covance
Location:
Reference: 2017-14581
Closing Date: 28 Feb 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

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.

Requirements:

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

Apply for this job: Senior Clinical Research Associate

Contact Information:

Address:  Head Office
Maidenhead Office Park, Westacott Way, Littlewick Green, Maidenhead
SL6 3QH
England
Website:  Visit Our Web Site

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