Clinical Research Associate (CRA)

Roles & Responsibilities
• Manage and drive study start-up activities including Pre-SIV and site activation tasks
• Act as primary point of contact for assigned sites during start-up and activation phases
• Build and maintain strong relationships with investigators and site staff
• Support feasibility, pre-qualification, and qualification activities including remote qualification visits
• Prepare, negotiate, and facilitate execution of Confidentiality Agreements and amendments
• Manage country and site-level Trial Master File (TMF) documentation ensuring first-time quality
• Configure, collect, review, and approve essential regulatory documents for site readiness and activation
• Customize, review, and negotiate country and site-specific Informed Consent Forms and translations
• Prepare and submit IRB/IEC and regulatory authority applications and manage approvals
• Forecast, plan, and track IRB/IEC, regulatory submissions, and site activation timelines
• Update and maintain Clinical Trial Management Systems and other clinical systems accurately
• Identify, resolve, or escalate site risks related to timelines, training, data quality, or compliance
• Support sites with system access and ensure completion of required study training
• Ensure assigned sites are audit- and inspection-ready at all times
• Maintain compliance with ICH-GCP, local regulations, sponsor requirements, and Parexel SOPs
• Support protocol amendments and maintenance activities through study close-out
• Collaborate with cross-functional teams to meet project milestones and deliverables
• Maintain timely completion of administrative tasks including timesheets, expenses, and metrics
• Contribute as a subject matter expert and mentor to other team members

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, or other health-related discipline
• Nursing qualification or equivalent clinical research experience may be considered

Experience
• Substantial experience in clinical trial start-up activities
• Prior experience in clinical research with strong understanding of trial methodology and terminology
• Experience working with IRB/IEC, regulatory submissions, and site activation processes

Skills
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
• Proven problem-solving, analytical, and decision-making skills
• Excellent organisational, time management, and prioritisation abilities
• Strong written, verbal, and interpersonal communication skills
• Proficiency in CTMS, eTMF, and MS Office applications
• Ability to work independently and in matrixed, virtual teams
• High attention to detail with strong quality and compliance focus
• Ability to work across cultures and manage multiple stakeholders
• Client-focused mindset with flexibility and adaptability

About the Company
Parexel is a leading global contract research organization supporting the development of innovative therapies across a broad range of therapeutic areas. With a strong focus on patient safety, regulatory compliance, and operational excellence, Parexel partners with sponsors worldwide to accelerate clinical development and bring life-changing treatments to patients faster.