Senior Clinical Research Associate II – Oncology

Jobtailor; Deutschland; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Clinical Monitor to oversee oncology trials in a fast-paced, regulated environment. You will conduct site visits, monitor data integrity, verify informed consent, and ensure compliance with study protocols.

The role requires 5+ years in clinical monitoring, nursing or allied health background, travel 30–50% (domestic and international). You will train site staff, liaise with vendors, and coordinate project activities while maintaining high quality and patient

Qualifikationen

• University degree or allied health certification from an accredited institution.
• 5+ years of Clinical Monitoring experience.
• Oncology experience; early phase preferred.
• 30-50% overnight travel.
• Ability to work in a fast-paced environment with strict study protocol and timeline requirements.
• Regulatory compliance and data integrity knowledge.
• Experience with Fortrea or similar data management systems.

Aufgaben

• Provide a high standard of care for participants in clinical trials and respond to emergency situations per clinical research standards.
• Perform routine monitoring and close-out of clinical sites.
• Maintain study files and conduct pre-study and initiation visits.
• Liaise with vendors and manage study sites according to project plans.
• Verify informed consent procedures and protocol requirements comply with regulatory requirements.
• Verify data integrity of Case Report Forms and other data collection tools.
• Monitor data for missing or implausible values and assist with training new staff.

Kenntnisse

Clinical Monitoring Experience

Oncology Experience

Regulatory Compliance

Data Management Systems

Teamwork and People Skills

Ausbildung

Bachelor's degree or Certification in Allied Health

Tools

Fortrea

Electronic Data Environment

Data Collection Tools

Jobbeschreibung

Responsibilities

• Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards
• Perform routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions to safely enter patients into the study
• Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements
• Verify the integrity of data submitted on Case Report Forms and other data collection tools
• Monitor data for missing or implausible data
• Manage registries according to project plans and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, reports, narratives, and follow-up
• Independently perform CRF review, query generation, and resolution using Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact
• Perform other duties assigned by management
• Travel frequently to client and site locations, including occasional domestic and international travel

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 5+ years of Clinical Monitoring experience
• Oncology experience; early phase preferred
• 30-50% overnight travel
• Comfortable working in a fast-paced environment with strict study protocol and timeline requirements
• Ability to adapt to constantly changing priorities
• Teamwork and people skills
• Ability to work in a technology-based electronic data environment
• Ability to sit for extended periods and operate a vehicle safely
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Occasional crouching, stooping, frequent bending and twisting of upper body and neck
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Light to moderate lifting and carrying objects including luggage and laptop computer, maximum 15-20 lbs
• Regular and consistent attendance
• Varied hours may be required

Core Competencies

Demonstrates expertise in Clinical Monitoring and Oncology, ensuring compliance with regulatory requirements and maintaining data integrity. Proficient in managing clinical trials, conducting site visits, and training staff in a fast-paced environment.

Highest-signal resume keywords

• Clinical Monitoring Experience
• Oncology Experience
• Regulatory Compliance
• Data Management Systems
• Teamwork and People Skills

ATS Optimization Keywords

Hard Skills

• Clinical Trial Management
• Case Report Form Review
• Serious Adverse Event Reporting
• Data Integrity Verification
• Feasibility Assessment

Soft Skills

• Adaptability
• Teamwork
• Communication

Certifications & Qualifications

• Nursing Licensure
• Allied Health Certification

Industry Keywords

• Clinical Trials
• Oncology
• Study Protocol
• Project Plans
• Vendor Liaison

Tools & Technologies

• Fortrea
• Electronic Data Environment
• Data Collection Tools