Clinical Research Associate (CRA)

Job title: Clinical Research Associate (CRA)

About the Role As a Clinical Research Associate (CRA) at Parexel, you will monitor investigator sites to ensure patient safety, data quality, and regulatory compliance, while driving trials from start-up through close-out. This field-based role involves traveling to sites, building relationships with investigators and site staff, and coordinating with global teams across therapeutic areas to bring therapies to patients faster. Parexel values curiosity, accountability, and integrity, with opportunities to grow personally and professionally.

What You'll Do

• Start-up activities: act as Parexel’s direct point of contact with assigned sites; ensure quality and delivery during start-up; build relationships with investigators and site staff; conduct country-specific feasibility and site pre-qualification/qualification; prepare, negotiate, and facilitate execution of Confidentiality Agreements, Clinical Site Agreements and amendments; conduct remote Qualification Visits; generate visit reports; develop strategy for country/site specific regulatory documents and amendments; customize, review, and negotiate Informed Consent Forms and translations; prepare and submit IRB/IEC and MoH/RA applications; update the trial master file; forecast, manage and revise plans for site activation, patient recruitment and retention; update CTMS; address site questions or issues and escalate as needed; ensure site access to study systems and required training; participate in investigator and regulatory meetings, audits, and inspections.
• Maintenance and ongoing site management: act as Parexel’s direct contact with sites during maintenance; assess and ensure study integrity and protocol adherence; build and maintain relationships with investigators and site staff; ensure training and system access; evaluate site staff assignments and implement corrective actions; address issues from previous visits; respond to site questions; conduct on-site visits including initiation and facilities assessments; perform remote visits as needed; collect, review and approve updated site documentation; evaluate site recruitment and provide strategies for improvement; monitor data quality, CRF entries, queries, and SAEs; review site payments; follow up on test article supply, destruction/return status; collect and review QA issues and implement follow-up actions.
• Global collaboration and accountability: participate in external/internal meetings, audits, and regulatory inspections; proactively update management on progress and risks; maintain timely CTMS records.

What We're Looking For

• Soft skills: communicator, detail-oriented, flexible, organized, problem-solver, self-starter.
• Ability to work with limited oversight, take accountability, travel to investigator sites as needed, and collaborate cross-functionally across global teams.
• Commitment to patient safety, data integrity, and adherence to regulatory requirements. You are trained on data up to October 2023.