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Job Details

CRA Belgium

Company: Syneos Health
Location:
Reference: IH/18003738
Closing Date: 25 May 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

We are looking for an enthusiastic CRA for our Strategic Resourcing department.

Requirements:

 


Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.      

 

Syneos Health is looking for new and enthusiastic colleague to join our Belgian Strategic Resourcing department as a CRA. This means that you will be fully employed by Syneos Health and you will solely be working for our client, a pharmaceutical company located in Brussels.

 

The CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. The specific tasks will be:

 

  • Develops strong site relationships and ensures continuity of site relationships though all phases of the trial
  • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
  • Gains an in-depth understanding of the study protocol and related procedures.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased, Subjects’ right, safety and well-being are protected
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
  • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.
  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
  • Supports and/or leads audit/inspection activities as needed

 

For this role we are looking for a colleague with a relevant education and a minimum of two years of monitoring experience within pharma or CRO.

 

Would you like to join our team?

Please contact us, so that we can tell you more about what our organization has to offer. You can contact our Benelux recruiters Irene Houtsma or Eveline Wigtman via Beneluxjobs@inventivhealth.com and we are looking forward to get to know you.

 

Apply for this job: CRA Belgium

Contact Information:

Address:  France
41 rue des trois Fontanot 92 000 Nanterre

France
Website:  Visit Our Web Site

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