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Site Monitor Ii / Clinical Research Associate Ii (Oncology Experience Required) - Germany (Remote)

3+ years
Not Disclosed
10 Dec. 4, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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