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Job Details

Lead Clinical Research Associate

Company: CROMSOURCE
Location: Home-based (Belgium)
Reference: HQ00000503
Closing Date: 10 May 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

The responsibilities of the Clinical Lead are to oversee the clinical site management aspect of designated projects at a local or international level in accordance with CLIENT SOPs. As CL responsibilities will include managing clinical monitoring activities and liaising with project management and the sponsor (if appropriate) to ensure that the clinical deliverables are met.  

Requirements:

  • Substantial monitoring experience or equivalent experience in clinical research.
  • Fluent in German
  • Competent in written and oral English
  • Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience
  • Holds a driving license
  • IT literate
  • Excellent interpersonal, site management, relationship building, verbal and written communication skills including excellent presentation skills
  • Client focused approach to work
  • A flexible attitude with respect to work assignments, new learning and travel (overnight, weekend and international travel may be required)
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of teamwork
  • Sense of urgency in completing assigned tasks

Responsibilities:

  • Manage the clinical team to ensure that the clinical deliverables are met.
  • Function as mentor for CRA team members to ensure study specific training for CRAs and that the sites are effectively managed
  • Perform co-monitoring visits with less experienced CRAs or at problem sites, as required, to identify possible areas for training and address these with the local training manager where applicable
  • If appropriate, collect investigator site regulatory documents and perform Quality Check prior to submission to EC, Regulatory Authority and SRP review
  • Track the flow of regulatory documents for all projects responsible for in order to coordinate and deliver the appropriate regulatory documents to meet regulatory and ethics committee submission dates
  • Ensure that the site personnel are adhering to the protocol and address any issues concerning protocol non-compliance with the principal investigator
  • Provide study specific tools, site-level documents (site recruitment plan), ensure the review and changes maintaining
  • Ensure the effective and timely co-ordination of the supply (and subsequent disposal) of clinical materials to the site to ensure that the site can start to actively recruit patients as soon as ethical approval at the site has been granted
  • Review reports generated by other CRAs assigned to the project in the region.  Highlight common issues and address these with the team as a training need.  Raise concerns with the Project Manager/ CL or Manager, Clinical Operations, as appropriate  
  • Identify common data errors and provide feedback to the team
  • Prepare and/or adapt all recruitment related templates to add any site-specific information to the templates before using. Communicate the patient recruitment and retention tactics to the Clinical team
  • Maintain project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked.  Provide status updates to the Project Manager, CL and client as required
  • Assist with the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.
  • Responsibilities will also include some on site monitoring/co-monitoring to ensure familiarity with the protocol and the opportunity to identify areas that may require additional training
  • Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines.  Identify training issues and provide feedback to the team

Our benefits when working in Belgium: 

  • Dedicated Line Manager
  • Monthly meetings with line manager
  • Employee satisfaction survey - your feedback is important for continuous improvement
  • Annual appraisals development planning
  • Yearly team event
  • New Year's diner
  • Group and hospitalization insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Car with fuel card   

Why choose TalentSource Life Sciences/Cromsource? 
  
Cromsource is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do. 
  
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.  
  
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge 
Cromsource comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent.  We our open, friendly and approachable and aim to support you through the recruitment process every step of the way. 
For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.  Most of our roles are permanent positions with Cromsource and you will be working on studies for just one client. 

Keywords:

Lead Clinical Research Associate; Clinical Monitoring; German

Apply for this job: Lead Clinical Research Associate

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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