Senior Initiation Clinical Research Associate(Study Start-Up)

As a Senior initiation Clinical Research Associate would will act as Parexel’s direct point of contact with assigned sites and take accountable for quality and delivery during the start-up phase.

You will furthermore build relationships with investigators and site staff and conduct, drive and manage country specific feasibility and/or site prequalification 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, 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. o IRB/IEC and MoH / RA submission/approval

o Site activation

o Patient recruitment & retentionUpdate 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, including but not limited to: o potential issues or risks with site activation timelines, issues with patient recruitment strategy

o deficiencies in training, data quality or integrity

o 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 startActively 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 any issues.Build relationships with investigators and site staff.Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.Address/evaluate/resolve issues pending from the previous visit, if any.Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.Conduct remote visits/contacts as requested/needed.Generate visit/contact report.Review & follow-up site payment status.Follow-up on CRF data entry, query status, and SAEs.Develop expertise to become a subject matter expert.Work in a self-driven capacity, with limited need for oversight.QualificationsProfessional experience:At least 5 years of experience in similar positionWork in a self-driven capacity, with limited need for oversight.Skills:Able to take initiative and work independently, and to proactively seek guidance when necessary.Client focused approach to work.Ability to interact professionally within a client organization.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.Willingness to work in a matrix environment and to value the importance of teamwork.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.Effective time management in order to meet study needs, team objectives, and department goals.Developing ability to work across cultures.Ability to successfully work in a (‘virtual’) team environment.Education:Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience