Clinical Research Associate II - Senior

Responsibilities

• Act as the direct contact for assigned clinical sites to ensure study integrity and protocol adherence.
• Perform on-site and remote monitoring visits, including Qualification, Initiation, and close-out visits.
• Build and maintain professional relationships with investigators and site staff.
• Evaluate site recruitment plans and provide strategic recommendations for improvement.
• Manage site documentation, regulatory files, and Trial Master File (TMF) submissions to ensure audit readiness.
• Monitor and manage test article/study supply, including accountability and destruction.
• Identify and resolve site issues, including data quality concerns, documentation deficiencies, and training needs.
• Ensure compliance with ICH-GCP, local regulations, and Parexel Standard Operating Procedures (SOPs).
• Update Clinical Trial Management Systems (CTMS) and other electronic systems (EDC, IVRS) regularly.

Requirements

• Proven site management experience or equivalent experience in clinical research.
• Strong knowledge of clinical research methodology, terminology, and ICH-GCP guidelines.
• Degree in biological science, pharmacy, or a related health discipline (or equivalent nursing qualification).
• Proficiency with computer systems including CTMS, EDMS, and MS Office (Excel, Word).
• Valid driver's license.
• Willingness to travel extensively to support assigned clinical sites.
• Strong interpersonal, verbal, and written communication skills.
• Ability to work independently and manage multiple tasks within project timelines.

About the Company

Parexel is a global leader in clinical research, dedicated to bringing innovative treatments to patients faster. We foster a supportive, inclusive, and patient-focused environment where employees can grow through diverse therapeutic exposure and advanced professional development programs.