Senior Clinical Research Associate – Oncology
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Job Description
Senior Clinical Research Associate monitoring oncology trials for Parexel, a global clinical development partner. Ensuring site compliance, patient safety, data integrity, and regulatory readiness.
Responsibilities:
- Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites
- Evaluate site performance and provide recommendations for site-specific actions
- Verify informed consent processes are appropriately conducted and documented
- Assess patient safety and clinical data integrity
- Conduct remote and on-site monitoring activities according to monitoring plans
- Perform source document review and verification
- Manage protocol deviation reporting, follow-up activities, and data query resolution
- Review investigational product accountability and related documentation
- Document monitoring findings and study activities
- Ensure appropriately trained and delegated site personnel perform study activities
- Maintain tracking of observations, action items, site status, and study progress
- Review essential study records for inspection readiness
- Participate in investigator, sponsor, monitoring, and project team meetings
- Collaborate with the primary Site Manager and stakeholders to support study objectives, deliverables, and timelines
Requirements:
- Bachelor's degree, Registered Nurse (RN), or an equivalent combination of education, training, and experience
- Experience in clinical research monitoring with oncology trial experience and knowledge of RECIST criteria
- Knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial processes
- Experience conducting on-site and remote monitoring activities
- Strong verbal and written communication, presentation, organizational, and interpersonal skills
- Ability to build and maintain effective relationships with investigator site personnel and study stakeholders
- Proficiency in the local language
- Advanced-level or fluent English language skills
- Experience working within sponsor-dedicated clinical research environments preferred
Benefits:
- Remote/home-based capacity
- Continuous learning
- Professional development
- Flexible working arrangements
- Growth-oriented environment
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