Clinical Research Associate II, Phase I

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

📋 Description

• Deliver exceptional care to participants involved in Phase I clinical trials

• Address emergency situations in accordance with clinical research protocols

• Oversee clinical study sites, which includes routine monitoring and close-out visits

• Maintain study documentation and perform pre-study and initiation visits

• Collaborate with vendors

• Manage study sites in alignment with project plans

• Ensure study personnel receive the necessary materials and guidance

• Confirm that informed consent procedures and protocol specifications meet regulatory standards

• Validate the integrity of the Case Report Form and other data through source-document monitoring

• Monitor data for any missing or implausible information

• Administer registries and conduct feasibility studies upon request

• Complete reporting, narratives, and follow-ups for Serious Adverse Events

• Review CRFs and generate as well as resolve queries using Fortrea or client data management systems

• Assist in training new team members through co-monitoring

• Coordinate specific clinical projects as a Local Project Coordinator

• Serve as the local client contact when designated

• Undertake additional responsibilities assigned by management

⛳️ Requirements

• A university or college degree, or certification in a relevant allied health profession from an accredited institution (e.g., nursing licensure)

• At least 1 year of Clinical Monitoring experience

• Experience in Phase I trials

• Willingness to travel overnight 40-50% of the time

• Capability to thrive in a fast-paced, highly regulated clinical research environment

• Flexibility to adapt to shifting priorities

• Strong teamwork and interpersonal skills

• Comfort with technology-driven electronic data environments

• Ability to remain seated for extended periods and operate a vehicle safely

• Repetitive hand movements involving both hands, fingers, and wrists

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

• Proficiency in using both in-house and commercial computer software

• Ability to lift and carry 15-20 lbs

• Commitment to regular and consistent attendance

• Willingness to work varied hours as needed

🏝️ Benefits

• Option for remote work

• 40-50% overnight travel

• Continuous acceptance of applications