Study Start Up Specialist II

Benefits

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Start-up (from site identification through site activation): 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. Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments. May conduct remote Qualification Visits (QVs). Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines. Manage country and site level TMF issues ensuring documents' First Time Quality (FTQ) as well as providing direct resolution to reported site problems. Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (Site SIV Readiness/Greenlight 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 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, Update and maintain appropriate Clinical Trial Management System (CTMS) in a timely manner. 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. 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 internal and/or external meetings as per project needs, Sponsor's expectations and at Manager discretion Work in a self-driven capacity, with limited need for oversight. Proactively keep manager informed about work progress and any risk or issues Maintenance (from initiation through close out): 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 as needed during maintenance Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. Forecast, develop, manage, and revise plans and strategies for: IRB/IEC and MoH / RA submission/approval, Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. Overall Accountabilities from Site Identification to Close out: Ensure timely and accurate completion of project goals and update of applicable trial management systems with start -up and amendments Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required. Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis including performing regular reviews of country and site level data in clinical systems (e.g. CTMS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality. Ensure that assigned sites are audit and inspection ready Monitor and maintain compliance with ICH-GCP and applicable international and local regulations. Show commitment and perform consistent high quality work. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced,

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