Overzicht

Job Description

As an In-house CRA/Start-up Specialist, you are responsible for several tasks, depending on your skills and experience. 
You manage and drive the strategy for the Pre Site Initiation Visits (Pre SIV)/start-up tasks of the study. You also support protocol amendments if applicable. 

Responsibilities

  • You act as the company’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • You build relationships with investigators and site staff.
  • You 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 (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • You conduct remote Qualification Visits (QVs).
  • You generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
  • You develop a strategy to configure, distribute, and collect, and review and approve, high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. 
  • You customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • You prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • You submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • You forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval, site activation, patient recruitment & retention.
  • You update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • You promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc. 
  • You facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start. 
  • You actively participate in Investigator and other external or internal meetings, audits & regulatory inspections. 
  • You work in a self-driven capacity, with limited need for oversight.
  • You proactively keep manager informed about work progress and any issues.
  • Profile

  • You have a University degree related to life sciences or a medical assistant degree and you have a first experience in clinical research or more particularly in Pre SIV/Start-up tasks in a clinical study.
  • You have a good understanding of clinical trials methodology and terminology.
  • You are bilingual FR/EN and you have at least a B2 in Dutch.
  • You have strong problem-solving skills.
  • You are able to take initiative and work independently and to proactively seek guidance when necessary.
  • You have advanced presentation skills.
  • You have a client-focused approach
  • You have the ability to interact professionally within a client organization.
  • You have a flexible attitude with respect to work assignments and new learning.
  • You have the ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
  • You have the Willingness to work in a matrix environment and to value the importance of teamwork.
  • You have strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • You have strong interpersonal, verbal, and written communication skills.
  • You have the sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
  • You have strong time management skills in order to meet study needs, team objectives, and department goals.
  • You show commitment to and perform consistently a high-quality work.
  • You have the ability to successfully work in a (“virtual”) team environment.
  • You are able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
  • You pay attention to details