Initiation Clinical Research Associate II (Temp Contract)

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 prequalification and qualification activities, which may include: o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA). o Conduct remote Qualification Visits (QVs). • 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 (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. • Prepare and submit IRB/IEC 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: o IRB/IEC and MoH / RA submission/approval, o Site activation, o • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue • 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. • Actively participate in Investigator and other external or internal Meetings.QualificationsAt least 2 years of experience in similar position. Work in a self-driven capacity, with limited need for oversight. Strong problem solving skills • Able to take initiative and work independently, and to proactively seek guidance when necessary. • Excellent presentation skills. • Client focused approach to work. •• Flexible attitude with respect to work assignments and new learning. • Ability to prioritize multiple tasks, and achieve project timelines; • Strong ability to make appropriate decisions in ambiguous situations. 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. • Excellent interpersonal, verbal, and written communication skills in English • Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables. • Excellent time management in order to meet study needs, team objectives, and department goals. • Proven ability to work across cultures. • Shows commitment to and performs consistently high quality work. • Ability to successfully work in a (‘virtual’) team environment. • Consulting Skills. • Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned. • Attention to detail. Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience