Site Monitor II (Clinical Research Associate II) – Sponsor Dedicated (Oncology)
Location: Remote, Germany
About the Role
Parexel is seeking an experienced Site Monitor II (Clinical Research Associate II) with at least 3 years of Oncology monitoring experience. This fully remote position is part of our sponsor-dedicated model and offers the opportunity to make a meaningful impact by ensuring data quality, regulatory compliance, and patient safety across clinical trial sites. The role involves a mix of virtual and on-site monitoring to support study objectives.
Key Responsibilities
Monitoring Oversight and Study Conduct
Ensure site compliance with ICH GCP, protocol requirements, and regulatory standards.
Verify informed consent processes and documentation.
Conduct source document review/verification to ensure accurate and complete data in the Case Report Form (CRF).
Manage protocol deviations and follow-up actions.
Perform investigational product (IP) inventory, reconciliation, and compliance checks.
Document activities through monitoring reports, follow-up letters, communication logs, and project-specific documents.
Review data entry timeliness, missing pages, and outstanding queries, ensuring readiness for database locks.
Maintain and verify site-specific logs, including Site Visit Logs, Screening and Enrollment Logs, Delegation of Duties Logs, and IP Accountability Logs.
Collaboration
Work closely with the Site Manager, who serves as the primary liaison with site personnel.
Attend investigator meetings, sponsor meetings, and global monitoring/project team meetings.
Build strong relationships with investigators, site staff, and other stakeholders.
Compliance and Inspection Readiness
Conduct remote and on-site monitoring activities per the Study Monitoring Plan (SMP).
Ensure sites are audit and inspection ready at all times.
Manage adverse event monitoring and queries.
About Parexel
Parexel is a leading clinical research organization supporting studies across a broad range of therapeutic areas. Our contributions have been critical to the development of many of today’s top 50 best-selling drugs, as well as niche treatments that improve patient well-being.
Why Join Us?
At Parexel, you’ll work with heart, putting patient well-being first while being part of a team that drives innovation and supports life-changing therapies.
Qualifications
Experience & Skills
At least 3 years of Oncology monitoring experience.
Strong communication, networking, and relationship-building skills.
Ability to adapt to changing technologies and processes.
Fluency in German and English (advanced level required).
Proficiency in building effective relationships with site staff and stakeholders.
Education
Bachelor’s degree or Registered Nurse (RN) qualification in a related field.
Equivalent education, training, and experience will also be considered.
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