The Initiation Clinical Research Associate II ( iCRA II ) specializes 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.Your 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.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.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, collect, 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.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).Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.Knowledge and Experience: Previous experience in study set up / site initiation / study start-up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology. Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable.Skills: 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; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.#J-18808-Ljbffr
