Senior Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Deliver exceptional care to participants involved in clinical trials and manage emergency situations in accordance with clinical research protocols.

• Oversee all facets of study site monitoring, which includes routine assessments and the closing of clinical sites.

• Organize and maintain study documentation while conducting pre-study and initiation visits.

• Collaborate with vendors and supervise study sites in alignment with project objectives.

• Guarantee that study personnel are equipped with the necessary materials and instructions for the safe enrollment of patients into studies.

• Confirm that informed consent processes and protocol requirements adhere to relevant regulations.

• Ensure the accuracy of CRF and other gathered data through thorough source-document reviews.

• Monitor data for any missing or implausible values.

• Manage registries in accordance with project plans.

• Conduct feasibility studies upon request.

• Complete SAE reporting, including reports, narratives, and follow-ups.

• Perform CRF reviews, generate queries, and resolve issues within Fortrea or client data management systems.

• Assist in training new staff through co-monitoring activities.

• Act as a Local Project Coordinator for assigned clinical projects.

• Serve as the local client contact when designated.

• Carry out additional responsibilities as assigned by management.

⛳️ Requirements

• A university or college degree, or a certification in a relevant allied health field from an appropriately accredited institution.

• An example of a qualifying credential includes nursing licensure.

• A minimum of 5 years of experience in clinical monitoring.

• Experience in oncology, with a preference for early-phase trials.

• Willingness to travel overnight 30–50% of the time.

• Proficient in a fast-paced, ever-evolving, technology-driven environment.

• Capability to work with electronic data-collection systems.

• Ability to sit for prolonged periods and operate a vehicle safely.

• Competence in performing repetitive hand movements and quick, simple finger, hand, and wrist motions.

• Ability to crouch, stoop, bend, and twist the upper body and neck.

• Proficient in using both in-house and commercial software applications.

• Capability to lift and transport luggage and a laptop weighing between 15–20 lbs.

• Regular and consistent attendance is expected.

• Flexibility in working hours may be required.

🏝️ Benefits

• Target salary range of $125 - $140K.

• Option for remote work.

• Continuous acceptance of applications.

• Support for equal employment opportunity and accommodations.

• Access to a Global Talent Network opportunity.