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