In House CRA NCH

In House CRA needed for a 6-month contract. Candidate will be responsible for effectively managing and monitoring clinical trials for assigned projects, ensuring a high standard and delivering on time whilst maintaining an optimal interface with CROs and other appropriate team members.Responsibilities:
Provide guidance to CRAs from CRO Provide clinical trial management expertise Ensure ICH Guidelines, GCP and NCH SOPs are followed in all aspects of studies Complete day-to-day tasks independently and with the appropriate sense of urgency Participate in Project Team meetings and present status update on all operational aspects of clinical trials; be the primary point of contact for the assigned clinical trials Identify causes of problems and identify solutions Ensure clinical trial data accuracy Ensure timely recruitment of patients and smooth running of subsequent operations, including data flow Ensure draft CRF design through to finalization and printingKey Interfaces:
CROs, study investigators and study coordinators Colleagues from Clinical Operations Project team members both domestic and international: Clinical Research, Clinical Supplies, Quality Assurance, Drug Safety, Project Managers and others Data Management staff at CRO Statisticians internally or at CROPosition Requirements & Education:
At least 5 years of experience in clinical research and development
2-3 years experience in clinical trial management
Fundamental understanding of ICH GCP and relevant therapeutic area knowledge
Life science university degree
Broad knowledge and cross functional understanding of clinical trial methodology and logistics
Team player with ability to work independently
Effective time management and organizational skills
Consistent and follows through on commitments
Fluency in written and spoken EnglishSmith Hanley Consulting Group,a division of Smith Hanley, specializes in providing clinical trials staffing to national pharmaceutical companies offering long-term contract services of Statisticians, SAS Programmers, Data Managers, Clinical Research Associates and other clinical specialties. Our professional recruiters are recognized leaders in the industry by placing junior to senior candidates into rewarding positions within leading pharmaceutical companies throughout the United States. For more than twenty years, we have built extensive client relationships. We strive to help our candidates make decisions that are consistent with their professional values, priorities and goals as well as provide our clients with candidates that meet their employment needs. www.shcgpharm.com


REQUIREMENTS
Pharm Group