Senior Clinical Research Associate II – Oncology

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Stellenbeschreibung:

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.