*CRA or Senior CRA - office-based in Basel or home-based throughout Switzerland*
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The world's leading pharmaceutical services organization is powering the next generation of healthcare.  If you want to make a difference in global healthcare, Quintiles is the place for you. You'll be connected with an organization that is changing the way drugs are developed, profiled and marketed. More than 23,000 people throughout the world have already chosen to join Quintiles.
 
We currently have an exciting opportunity for a Clinical Research Associate or Senior Clinical Research Associate available.The position will be office-based in Basel  or home-based throughout Switzerland.
 
We are looking to recruit committed individuals to work in our Global Functional Resourcing department providing essential support for dedicated customers in Switzerland. The Clinical Research Associate or Senior Clinical Research Associate provides support to a clinical project team including maintenance of documentation, clinical tracking and information retrieval. Assists with general administrative functions as required. Maintains and manages data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members.
 
PURPOSE
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
 
The key duties and responsibilities of the role include:
  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
  • Act as a mentor for clinical staff including conducting co-monitoring and training visits.
  • May provide assistance to the CTL with design of study tools, documents and processes.
  
At Quintiles we value individuality, fresh ideas, and the contribution that our employees make to our success. In return we offer career opportunities providing flexibility and growth across the organization, competitive salary and benefits package, work-life balance initiatives and social events. These are just some of the incentives we have to offer. Join Quintiles. It's work worth doing!
 
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • In depth therapeutic and protocol knowledge as provided in company training
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Strong written and verbal communication skills
  • Excellent communication skills in German language including good command of English is a must, additional capability of Italian or French language is an advantage
  • Excellent organizational and problem-solving skills
  • Effective time management skills
  • Ability to manage competing priorities
  • Effective mentoring and training skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor's degree in a health care or other scientific discipline or educational equivalent and minimum 1 year of on-site monitoring experience; or equivalent combination of education, training and experience

 

KEY WORDS: CRA, Clinical Research Associate, Senior CRA, SCRA, klinischer Monitor, CRO, Pharma, Monitor, Monitoring, Schweiz, klinische Forschung, Studien, Studienkoordinator, Studienkoordination, study coordinator

 
Additional Information
Location | | | Start Date 2013-06-11
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 11-Jun-2013


Contact Information
Company Name Quintiles Telephone No Not Provided
Contact Name Site Link Not Provided
 

       

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