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

3+ years

Not Disclosed

Remote - Europe

10 Dec. 14, 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

Here’s a refined version of the Site Monitor II (Clinical Research Associate II) role at Parexel:

Position: Site Monitor II (Clinical Research Associate II)

Location: Remote (Based in Germany)
Company: Parexel

About Parexel

Parexel is a global leader in clinical research and healthcare intelligence. We support clinical trials across various therapeutic areas, collaborating with the largest pharmaceutical companies and innovative biotech firms to bring therapies to market. By joining us, you’ll be part of a team that is passionate about making a positive impact on the lives of patients worldwide.

About the Role

The Site Monitor II (Clinical Research Associate II) will be responsible for ensuring the integrity and quality of clinical trial data, in compliance with ICH GCP and local regulatory requirements. The role will primarily be remote, with virtual monitoring to supplement on-site visits. The Site Monitor II will collaborate with Site Managers and investigators to ensure protocol compliance and site inspection readiness.

Key Responsibilities

Monitoring & Compliance: Ensure regulatory, ICH-GCP, and protocol compliance at clinical sites. Evaluate site performance and provide action plans for any issues.
Informed Consent & Data Integrity: Ensure proper informed consent processes and protect subject confidentiality. Verify clinical data in Case Report Forms (CRFs) and source documents.
Protocol Deviation & Issue Management: Report protocol deviations and manage follow-up actions. Provide guidance on query resolution and ensure timely closure.
Investigational Product (IP) Management: Oversee IP dispensing, storage, and accountability. Ensure IP compliance, especially related to blinded or randomized data.
Documentation & Tracking: Maintain accurate records of monitoring activities, including reports, communication logs, and follow-up actions. Ensure site logs and training records are up-to-date.
Collaboration: Work closely with Site Managers and site staff. Attend investigator meetings and global clinical monitoring meetings.

Who We're Looking For

To succeed in this role, you should have the following qualifications:

Skills

Oncology Monitoring Experience: At least 3 years of oncology clinical monitoring experience.
Communication & Collaboration: Strong networking and relationship-building skills. Proficiency in local language and advanced English is required.
Adaptability: Ability to manage changing technologies and processes, overcoming barriers during implementation.
Problem Solving: Ability to identify issues and work with site staff and stakeholders to resolve them efficiently.
Attention to Detail: Ensure the integrity and accuracy of clinical trial data and documentation.

Education

Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent experience.

Why Join Parexel?

At Parexel, we are committed to putting patient well-being first. As part of our team, you’ll have the opportunity to contribute to cutting-edge clinical trials, working with world-renowned experts and organizations. We offer a supportive and dynamic environment where you can grow professionally and make an impact in the clinical research field.

Interested?

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This version emphasizes the key responsibilities, required skills, and qualifications in a concise and engaging manner, while highlighting Parexel's supportive and innovative work environment. Let me know if you'd like further adjustments!

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

Job Description

Position: Site Monitor II (Clinical Research Associate II)

About Parexel

About the Role

Key Responsibilities

Who We're Looking For

Skills

Education

Why Join Parexel?

Interested?

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