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This weeks Top Job is...

Ref No:	KP-4026
Job Title:	CLINICAL RESEARCH ASSOCIATE 2 / CRA 2
Description:	BACKGROUND Chiltern is a well established privately owned full service (Phase I-IV) Clinical Research Organization, with over 1400 employees and 23 offices throughout North and South America, Europe (both Eastern and Western) and Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.   We are looking to recruit additional CRAs to join our Clinical Monitoring team in the USA, preferably in the mid US or West Coast regions, however we will consider other locations as well.   PRIMARY DUTIES The CRA 2 is an essential member of a Chiltern Clinical Project Team and is responsible for the execution of a Clinical Research Project. The degree of responsibility given to a CRA 2 shall reflect his/her experience and the level of contribution, which he/she can make to that project.   Clinical Monitoring Activities: - To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits. - To identify potential centres for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required. - To ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies. - To be proactive in all dealings with study sites. - To track patient recruitment by contacting investigators as specified for the study. - To provide assistance in the production of Case Report Forms and protocol design. - To liaise with data management regarding data flow and data query processing. - To be accountable for ensuring that all relevant study documentation is present for study sites. - To liaise with all other appropriate departments within Chiltern to ensure the smooth running of the study. - To assemble files and ensure documents for the trial master file accurately reflect the progress of the study. - Assist in the organisation of meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.   Performance and Quality: - Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements. - Ensure awareness of project-specific quality and performance standards and ensure that these are adequately documented, communicated and understood. - To attend all relevant training and SOP training sessions. - Actively participate in training sessions and workshops.   General Duties: - To liaise with other members of the Chiltern Project Team and clients effectively. - To maintain awareness of current development in the therapeutic areas relevant to his/her project(s), by reading scientific and medical literature. - To ensure that all internal systems are routinely updated as appropriate.
Requirements:	QUALIFICATIONS - A University degree in a Biomedical or related Life Science, alternatively equivalent previous experience in a Clinical Development, Pharmacy or Nursing environment. - Previous CRA experience within clinical research. - Respiratory and / or CNS clinical trial experience would be preferred. - An understanding of the basics of physiology and pharmacology. - Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. - Good oral and written communication, organisational skills and personal presentation. - Experience working in a team environment. - Understanding of the principles of ICH GCP and regulatory requirements.   ADDITIONAL INFORMATION This is a full time, permanent position that can be based at any of our US offices (Wilmington - NC, Bristol - TN, Winston Salem – NC) or from a Home Based location.  There is a preference for mid-US and West Coast locations however we will consider experienced CRAs anywhere in the USA.   You must be able to travel locally and internationally (as required) without any restrictions. USA travel may be frequent. Overnight stays will be required.   Chiltern’s unique corporate culture encourages a healthy balance of personal life and work.  We offer an excellent salary and benefits package to include medical, dental, vision, company matching 401K, excellent vacation & holiday, paid life insurance, AD&D, long and short term disability and many other employee benefits.   For a confidential and informal discussion, please telephone our Senior Manager, Internal Recruitment - Kaushik (KP) Pankhania on +44 (0)1753 216 680. To apply, please send your CV to kp@chiltern.com   For more information about Chiltern, our web site is www.chiltern.com
Salary:	Competitive Salary + Benefits
Position Type:	Full Time - Permanent , USA - Wyoming
Contact:	Kaushik Pankhania
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