Clinical Research Associate (CRA)
Tfs Trial Form Support AB / Biomedicinjobb / Stockholm
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TFS is a CRO with highly committed and competent employees, who either work as outsourced consultants at pharmaceutical or biotech companies,
or work with project assignments in-house. A CRA is a member of the Study Team, and is responsible for the initiation, monitoring and termination of tasks during the study process according to company policies, SOPs and regulatory requirements. The position is full-time and you will be located at our Swedish office in Stockholm or at one of our client?s facilities.
The main responsibilities of the CRA will include:
• Preparing and conducting pre-study activities, site selection, initiation visits, routine monitoring and close-out visits.
• Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities.
• Preparing bio bank agreements.
• Preparing Data Inspection applications.
• Preparing pharmacy agreements.
• Coordinating and being responsible for the completion of study documentation such as: CRFs, patient diaries, Monitoring Manual, Study Operations Manual, Source Data Verification Plan etc.
• Planning and participating at Investigator?s meeting(s).
• Responsible for the site(s) and on-site management during the study process.
• Ordering and coordinating study supplies.
• Preparing study documentation and assisting the Clinical Quality Assurance Manager/regulatory authorities during audits/inspections in-house or on site.
• Negotiating contracts with the clinics, local/central laboratory(ies)/pharmacy etc.
• Responsibility for the final archiving of all study documentation in-house.
The CRA should act as the main communication link between TFS/Sponsor and the study sites for activities related to site management.
Requirements/Qualifications:
• Suitable academic education in life sciences.
• At least one to two years? experience as a CRA.
• Good communication skills in English.
• Good organizational skills and social skills.
• Ability to maintain effective, professional communication.
• Ability to prioritize and manage multiple tasks.
• Good pedagogical skills.
• Valid driving license.
• Possibility to travel 60 % per week (three days a week).
TFS Trial Form Support will offer:
A dynamic and growth-oriented organization with a work environment distinguished
by professionalism, integrity and responsibility. We value a close working relation with our customers who are important and highly appreciated. As a consultant at TFS you have your reporting line manager locally, who will support and coach you in your work.
Welcome to join us and to contribute in placing TFS among the top 7 worldwide CROs.
Your job will make a difference!
For more information about this position please contact:
Lotta Samuelsson, HR Manager
E-mail address; lotta.samuelsson[at]tfscro.com
Phone number; +46 (0)46 280 18 31
or
Ann-Charlotte Cederholm, HR Assistant
E-mail address; ann-charlotte.cederholm[at]tfscro.com
Phoen number; +46 (0)46 280 19 75
We are looking forward to receiving your application with included CV and a personal letter. We practice a continuous selection procedure, so please submit your application via this link
http://www.webforum.com/form/tfsjobb/form.asp?sid=596106745 or via the link provided on our website as soon as possible.
Publiceringsdatum2013-04-11KörkortskravB
Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duAnsökan kan tyvärr inte göras via e-post.
FöretagTFS TRIAL FORM SUPPORT AB
AdressTFS TRIAL FORM SUPPORT AB
Box 165
22100 LUND
KontorsadressRuben Rausings gata 11 A
LUND
Övriga kontaktuppgifterTelefonnummer: 046-280 18 00
Jobbnummer 1518843
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