Senior CRA

Urgent
Posted 2 months ago
Germany, Remote
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Job Description

Senior Clinical Research Associate (Senior CRA) Homeworking

AL Solutions are exclusively partnered with a niche rare disease focused global CRO, who are actively searching for an experienced CRA to join their team in Germany.

As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in rare disease studies. 

This company harness insights, commercial and scientific depth, and expertise to empower clients to achieve goals. You will be at the forefront of their team.

Responsibilities

  • Contribute to site identification and feasibility activities
  • Be involved in site management, training site staff, ensure supply of study material, IMP and trial documents, recruitment updates.
  • Collect and assess essential documents and perform reconciliation of Investigator Site File.
  • Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits.
  • Assesses IP accountability, dispensation, and compliance at the investigative sites.
  • Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
  • knowledge of applications and systems. (e.g. CTMS, eTMF, IVRS/IWRS and EDC).
  • Facilitates site audits and audit finding resolutions.
  • May supervise work of, or mentor, less experienced CRAs.
  • Serve as an observational visit leader.

Requirements:

  • Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
  • Experienced Clinical Research Associate
  • Excellent communication skills
  • Proficiency in written and spoken English and German
  • Good knowledge of European clinical research regulations and ICH-GCP
  • Multiple therapeutic experiences and proven ability to gain in-depth protocol knowledge
  • Ability to establish/maintain good relationships with sites/colleagues/clients
  • Ability to make decisions independently / Strong problem-solving skills

Apply

AL Solutions are a niche Life Science recruitment consultancy. We source the best talent in the industry, placing professionals in the finest positions across Europe for a variety of biotechnology, pharmaceutical and Contract Research Organisations, ranging from small start-ups to large global corporations.

If you are interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.alsolutions.co.uk or reach out to us via:

Kyna Broadhead

+44 (0) 203 778 1455

kyna@alsolutions.co.uk