.When our values align, there's no limit to what we can achieve.The Initiation Clinical Research Associate II ( iCRA II ) specialises in performing all study start up activities for a clinical trial.You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study.The iCRA II can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.This role can be based either office-based in Madrid or Barcelona or decentralized in Spain.Key Accountabilities :Start-Up (from site identification through pre-initiation)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.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 (SRP) 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 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).Skills :Strong problem-solving skills.Able to take initiative and work independently, and to proactively seek guidance when necessary.Client focused approach to work.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.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.Fluent command of Spanish and English languages.Sense of urgency in completing assigned tasks and ability to assist others to meet study / country deliverables.Excellent time management to meet study needs, team objectives, and department goals
