Initiation Clinical Research Associate II / Study Coordinator

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 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:

o IRB/IEC and MoH / RA submission/approval,

o Site activation,

o 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.

Actively participate in Investigator and other external or internalQualifications

Experience/Education:Significant regulatory and/or site experience in clinical trialsEducated to degree level preferred (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experienceSound awareness of all relevant regulations, including GCPFluency in English is required