Location: Prefer eastern part of the country or Bucharest
Closing Date: 14 Apr 17
Salary (£): On Application
Chiltern is looking to recruit experienced monitors based in the Romania to work in the role of Senior Clinical Research Associate (SCRA).
Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.
Chiltern is looking to recruit experienced monitors based in the Romania to work in the role of Senior Clinical Research Associate (SCRA). This role offers excellent exposure to all therapeutic indication types and a defined career development.
The CRA is a high-profile role within the department, using their experience as a ‘knowledge resource’ to help other CRAs develop their skills.
The CRA will provide expert advice, guidance and general supervision to Clinical Monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, ensuring study completion on time and within budget. They may be called upon to interact independently with clients not directly involved in their projects, and to assist in some relevant departmental tasks.
We encourage the development of CRAs into the lead function giving co lead responsibilities where possible and excellent exposure. We also welcome applicants that want to be career monitors.
Duties & Responsibilities
• The successful applicant will be responsible for coordinating Phase I-IV clinical trials in Europe
• Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.
• Assist with document submissions to local authorities
• To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required
• Ensure that all study related communication including e-mail is tracked, printed and filed as required
• To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA
• To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study
• Mentor and train other CRA’s
• To assemble files and ensure documents for the trial master file accurately reflect the progress of the study
• Other Ad-Hoc CRA duties
• A BSc or BA degree in a biomedical or related life science, or nursing qualification
• Previous experience as a Clinical Research Associate
• Good clinical knowledge with an understanding of medical terminology
• An understanding of the basics of physiology and pharmacology
• Understanding of the principles of ICH GCP and regulatory requirements
• Experience using a clinical trial management system
• Preferable experience using a clinical trial management system (CPMS)
• Experience as a CRA on single site and/or multicentre trials
• Good oral and written communication, organizational skills and personal presentation
• The ability to communicate effectively in English
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office
The successful candidate will have well rounded and recent therapeutic experience within the areas of Biopharma.
• Full time and home based in Romania
• Working under an Independent Contractor Agreement initially (6 month contract), candidates will need to be Authorized Physical Person in Romania or have their own legal entity. We are in the process of setting up a legal entity in Romania, this should be in place in the next few months, we would then look for contractors to be moved to be employed by Chiltern.
• Preferably located in eastern part of the country or Bucharest or willing to travel for an average of 7 MVs per month to North-East of the country
• At least 3 years monitoring experience, previous homebased position would be considered an advantage
• Facilities to have a home office
• Work will be required away from Chiltern offices, at Sponsor offices, and will require national travel
• May also involve travel to meetings or attendance at conferences
• Overnight stays may be required
• No freelance applications or agency enquiries will be considered
Please submit your CV and a detailed covering letter explaining why you are suitable candidate. If you do not submit a covering letter this may affect your application
Please send your CV to email@example.com
For more information about Chiltern International, please visit our web site at www.chiltern.com
Successful candidates will have the opportunity to be part of a growing company with a strong brand and professional employees that care about the work they are involved in. Chiltern is constantly working to develop training capacity, therapeutic expertise, new technologies and processes to be one of the leading CROs globally.
Working for Chiltern will offer an excellent opportunity to raise your profile and develop your career whilst giving you the flexibility to enjoy a good work life balance.
Please note that if your experience does not mirror that of our requirements for this role you may not receive a response.
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.