Job Title: Site Monitor II (Clinical Research Associate II)
Department: Clinical Operations
Location: Remote (Germany)
Focus Area: Oncology Monitoring
Role Overview:
The Site Monitor II (Clinical Research Associate II) is responsible for monitoring and managing clinical trial activities at the site level to ensure data integrity, quality, and compliance with regulatory standards, ICH GCP, and local requirements. This role requires at least three years of oncology monitoring experience and involves a combination of on-site and remote monitoring activities.
Key Responsibilities:
Site Monitoring and Oversight:
Conduct site monitoring in line with the Study Monitoring Plan (SMP), ensuring regulatory and protocol compliance.
Perform source document review and verification, ensuring data accuracy and completeness in Case Report Forms (CRFs).
Manage protocol deviations, adverse event monitoring, and resolution of data queries within defined timelines.
Verify investigational product (IP) storage, reconciliation, and administration align with protocol and regulatory standards.
Review site-specific logs, including delegation of duties, screening/enrollment, and accountability logs, to ensure accuracy and compliance.
Ensure site staff are trained appropriately and documented in delegation logs, updating records as needed for protocol amendments or staffing changes.
Collaboration and Communication:
Act as a liaison with the primary Site Manager and investigator site staff, maintaining clear and effective communication.
Participate in investigator meetings, sponsor meetings, and clinical monitoring staff meetings as required.
Provide guidance to site personnel to support inspection readiness and protocol adherence.
Documentation and Reporting:
Maintain detailed monitoring reports, follow-up letters, communication logs, and other essential project documentation.
Track and manage observations, assigned action items, and data entry timeliness through appropriate systems.
Continuous Improvement and Compliance:
Adapt to evolving technologies and processes to improve efficiency and data quality.
Ensure equipment, facilities, and supplies meet clinical trial requirements, including expiration checks.
Support process enhancement initiatives and compliance with GCP and organizational procedures.
Qualifications and Skills:
Education and Experience:
Required: Bachelor’s degree or Registered Nurse (RN) qualification in a relevant field.
Minimum of 3 years of clinical monitoring experience in oncology studies.
Key Skills:
Strong relationship-building, networking, and communication skills (both verbal and written).
Adaptability to new technologies and ability to troubleshoot process challenges.
Proficient in local language and advanced fluency in English.
Effective stakeholder engagement and ability to collaborate across multidisciplinary teams.
Why Parexel?
Extensive involvement in clinical studies across diverse therapeutic areas, supporting top drug developments globally.
Collaborative and innovative culture with a focus on patient well-being and trial integrity.
Opportunities for professional growth and contributions to groundbreaking oncology research.
This is a fully remote, home-based position offering the opportunity to make a meaningful impact in the lives of patients worldwide.
Join us to help deliver innovative therapies while building strong, lasting relationships with industry leaders and peers.
Not the right role for you?
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