Company: Barrington James Clinical
Location: OFFICE BASED NRW
Closing Date: 10 Dec 16
Salary (£): Competitive
Candidates with a varied therapeutic area background are encouraged to apply. The successful candidate will also be able to perform additional project supporting functions such as monitoring report template/annotation prep, review of project plans, co-monitoring, site feasibility/selection activities, presentation at investigator meetings and acting as Lead CRA on projects.
CRA for mid size CRO, low hierarchy, lead CRA functions
Key responsibilities will include:
Provide clear communication between levels of project: from team, to site and report to overall project leaders
Developing, implementing and maintaining study documents, timelines, report formats, files, communication tools, budgets, and systems used in conducting a project
Perform routine site visits, including Pre-Study, Initiation, Routine and Closeout visits,
compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance
Assist Project Managers in study execution by acting as Lead CRA on projects and
facilitating communication with Clinical Monitoring team
Participate in TMF and on-site audits as requested
Responsible for site management and site staff performance
Participate in company-required training programs
Participate on BID defense meeting
Assure timely and accurate completion of Data Clarification Forms (DCFs).
Performs clinical data listings reviews as needed
Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution
Provide a high level of administrative functions to assure smooth project running
Life sciences background is required
University Degree in Medicine is an advantage
Expereinced in working home based
Experience in Regulatory Submissions / local regulations is an advantage
Experience with Electronic Data Capture is required
Excellent organizational and time management skills to handle multiple priorities
Ability to work and to take proper decisions under pressure
Flexibility to travel
Cost effective abilities
Social and soft skills
Excellent written and oral communication skills in German and English
If you are looking for a career within a transparent and non-hierarchical organisation then please contact me on +49 69 274 015 840 or via email with your CV email@example.com.
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