Senior Clinical Research Associate (Freelance)

Hobson Prior are working with a Global CRO who are seeking a Senior Clinical Research Associate (Freelance) to join them on a contract basis in Brussels. You will serve as the clinical sites' direct point of contact and will be responsible for managing site quality and delivery from site identification through close-out.

Job Responsibilities:

• Start-up (from site identification through pre initiation ­ tasks of Sr ICRA
• Act as direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships with investigators and site staff.
• Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
  - Preparation, negotiation, and facilitation of execution of Confidentiality Agreements, Clinical Site Agreements and any amendments.
  - Conduct remote Qualification Visits
• Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
• Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents and any updated or amended regulatory documentation.
• Customize, review, and negotiate as needed, country/site specific Informed Consent Forms, translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
• Forecast, develop, manage, and revise plans and strategies for:
  - IRB/IEC and MoH / RA submission/approval
  - Site activation
  - Patient recruitment & retention
• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
• Any other assigned duties.

Requirements:

• Bachelor's degree in life sciences (masters or phd is an advantage).
• Experience in study start-up.
• Minimum of three years' experience in independent on-site monitoring.
• Fluency in English French and Dutch.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.