Clinical Research Associate

Location Diegem
Discipline: Medical Device
Job type: Freelance
Contact name: Oliver Holding Fay

Contact email: o.fay@panda-int.com
Job ref: 15108
Published: about 1 month ago

Looking for a Clinical Research Associate who will:
Tasks:

  • Support CRA Resource Leader in resource planning and allocation of functionally sourced staff and contractors.
  • Assist in tracking of CRA workload and deliverables.
  • Supports efforts to ensure efficient use of functional resources to provide efficient and high quality deliverables.
  • Provide guidance and advice to Clinical Research Associates on company procedures and regulatory authority requirements.
  • Assists in coordination of training of Clinical Research Associates ensuring updates on specific requirements.
  • May perform accompanied site visits to assess and ensure quality and efficiency of Clinical Research Associates.
  • May participate in project management meetings and provide an overview of monitoring resources quality and workload on a regular basis.
  • Provide internal communication of important clinical data and events.
  • Facilitate and manage study start-up as directed to ensure responsive and efficient process: site qualification, clinical trial agreements and budget negotiation, IRB/EC submissions and approvals, and site initiation/training
  • Participate in departmental initiatives aimed at improving process and efficiency, in particular for the improvement of local process.
  • Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
Requirements:
Functional and Technical Competencies:
  • Solid knowledge of monitoring and site management processes.
  • Knowledge of current clinical regulations, standards and good clinical practices
  • Written and Verbal Communications
  • Good presentation skills and effectively influencing of others
Education & experience:
  • Minimum Bachelors/University degree or equivalent required. 4-6 years of relevant experience (or equivalent) required; Master’s with 3 years or. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
  • Requires understanding and application of EMEA regulations and standards applied in clinical areas and medical devices/combination products.
  • Clinical/medical background - a plus.
  • Requires at least 4 years of monitoring experience (medical device and pharma a plus, CRO monitoring experience – a plus)


LOCATION: Diegem (Belgium)

CONTRACT: 12 months (there is a high possibility of extension)

START DATE: ASAP

INTERESTED? Reach out to Beata Wydurska for more information by contacting +31 (0)20 20 44 502 or B.Wydurska@panda-int.com