Clinical Research Associate I/II and Senior CRA - (Any region)

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.

External Job Description

Parexel is looking for multiple Clinical research associates I, II and SR to join the US team in any region.

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, 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.

• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

• Work in a self-driven capacity, with limited need for oversight.

• Proactively keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site 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.

• Follow-up on and respond to appropriate site related questions.

• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

• Collect, review, and approve (if applicable) updated/amended site document