Initiation Clinical Research Associate I

Parexel is looking for an Initiation Clinical Research Associate to join our team in Mexico!

Working as an Initiation Clinical Research Associate (ICRA) you will be the direct point of contact with assigned sites located throughout North and South America and accountable for quality and delivery during the start-up phase. Duties will include preparation, negotiation, and facilitation of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments, Informed Consent Forms (ICF); Conduct remote Qualification Visits (QVs), Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
To be considered for this opportunity you must have clinical trials experience as a CRA, study nurse or site coordinator ideally with a university degree in a health-related discipline. Understanding of GCP and relevant regulations plus knowledge of submissions and ICF customizations is expected. This is a virtual team environment and your strong interpersonal and communication skills will help you to succeed. Fluency in English is required

Additional duties will include:
• Build relationships with investigators and site staff.
• Conduct, drive and manage country-specific feasibility and/or site prequalification and qualification activities, which may include: o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. o Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
• Develop a 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) 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.

Qualifications

Qualifications :
Experience/Education:

• Significant regulatory and/or site experience in clinical trials
• Educated to degree level preferred (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
• Sound awareness of all relevant regulations, including GCP
• Fluency in English is required