Medtronic Clinical Research Monitor in Budapest, Hungary
Clinical Research Monitor
Budapest, Budapest, Hungary
Apr 19, 2017
Clinical Research Monitor, Budapest, Hungary.
The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies.
Perform site monitoring visits inaccordance with the study Monitoring Plan to ensure compliance with the InvestigationalPlan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards,guidelines and policies.
Prepare site visit reports and correspondencefor all visits conducted in accordance with the study Monitoring Plan.
Communicate visit findings with sitepersonnel, ensure relevant follow-up.
Identification and escalation of protocoldeviations, discrepancies in data, and non-compliance to study protocols, applicableregulations, Good Clinical Practices and Standard Operating Procedures.
Identify site needs, provide solutionsto facilitate the clinical trial process.
Act as a primary point of contact forstudy sites as requested.
Assist in initial and ongoing site personneltraining as required.
Possess a working knowledge of diseasestate and investigational product.
Attend Investigator and/or Coordinator meetings.
Lead all relevant monitor responsibilities.
Key requirements :
Bachelor’s Degree in life sciences,nursing or other health related disciplines.
Min. 2 years of Clinical Research experience / Master’sdegree and no experience required.
Proficient knowledge of medical terminology.
Clear and effective communication skills.
Excellent interpersonal skills.
Experience working in a team/matrix environmentrequiring strong working relationships.
Ability to handle and prioritize multiple therapeuticareas and projects simultaneously.
Ability to work in a fast paced environment.
High attention to detail and accuracy
Excellent problem solving skills
Computer literacy (MS Word, Excel, PP).
Ability to travel upto 80% (may require also international travel).