Clinical Research Associate I/II/Senior

About the role

The Clinical Research Associate (CRA) will serve as Parexel’s primary liaison with assigned study sites, ensuring that clinical trials are conducted in accordance with protocols, regulatory requirements, and high‑quality standards. The role involves monitoring site performance from initiation through close‑out, supporting investigators, and safeguarding data integrity.

Key responsibilities

• Act as the direct contact for sites, building relationships with investigators and staff.
• Facilitate site access to study systems, ensure compliance with training requirements, and evaluate staff assignments.
• Identify, address, and resolve site issues, including documentation deficiencies and data quality concerns.
• Participate in investigator meetings, audits, and regulatory inspections.
• Collect, review, and approve updated site regulatory documents.
• Assess site recruitment plans and provide improvement strategies.
• Conduct qualification, initiation, and routine monitoring visits, both on‑site and remotely, and generate detailed visit reports.
• Manage study supply accountability, site payments, CRF data entry, query resolution, and SAE follow‑up.
• Deliver site‑specific training and perform facilities assessments.
• Update Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), IVRS, and SIS with accurate, timely data.

Required profile

• Demonstrated ability to act as a primary site contact and maintain strong investigator relationships.
• Proven judgment in evaluating data quality, site performance, and compliance issues.
• Experience conducting on‑site and remote monitoring visits and preparing comprehensive reports.
• Capability to manage study supplies, payments, and regulatory documentation.
• Strong organizational skills to meet project timelines and update trial management systems.

Required skills

• Proficiency with Clinical Trial Management Systems (CTMS).
• Experience using Electronic Data Capture (EDC) platforms.
• Familiarity with Interactive Voice Response Systems (IVRS).
• Knowledge of Study Information Systems (SIS) for site management.