Senior Initiation Clinical Research Assoiciate

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

The Serbian office is growing and we are looking for a Senior Initiation Clinical Research Associate. In this global role you will perfrom SSU tasks for a variety of European countries.

Act as Parexel’s 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 prequalificationand qualification activities, which may include:Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.Conduct remote Qualification Visits (QVs).Generate visit/contact reports, using judgment to identify site issues andproblem solving to direct resolution.Develop strategy to configure, distribute, and collect, and review andapprove, high quality country specific and/or site specific documents oressential regulatory documents (SRP) and any updated or amendedregulatory documentation.Customize, review, and negotiate as needed, country/site specificInformed Consent Forms (ICF), translations (within parameters ofcountry/regulatory/client requirements), and customize and negotiateany amendments.Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s),resolving conflicts, determining appropriate follow up until receipt of finalapproval.Submit all pertinent documentation to the trial master file as per projectplans/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.Promptly identify, use judgment and knowledge to address and resolveor escalate, any site question and/or issue, including but not limited to:potential issues or risks with site activation timelines, issues with patientrecruitment strategy, deficiencies in training, data quality or integrity,study non-compliance, etc.Facilitate and support allocated sites with access to relevant studysystems and ensure they are compliant with all project specific trainingrequirements prior to study start.Actively participate in Investigator and other external or internalWork in a self-driven capacity, with limited need for oversight.Proactively keep manager informed about work progress and anyissues.QualificationsKnowledge and ExperiencePrior CRO experience preferred in Study Start-UpSubstantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminologyStrong 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.Education

• Educated to degree level (biological science, pharmacy, or other health-related discipline)

SkillsClient focused approach to work.Flexible attitude with respect to work assignments and new learning.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.Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.Proven ability to work across cultures.Ability to successfully work in a (‘virtual’) team environment.Proficiency in English and great communication skillsAble to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.Holds a driver’s license where required.