Clinical Research Associate II, Phase I

This is a fully remote position, open to applicants in Colorado, +4 more states.

📋 Description

• Deliver a high level of care to participants involved in clinical trials

• Respond to emergencies according to clinical research protocols

• Conduct routine monitoring and closing activities for clinical sites

• Maintain comprehensive study documentation

• Carry out pre-study and initiation visits

• Collaborate with vendors

• Oversee study sites in alignment with project objectives

• Ensure that study personnel receive appropriate materials and instructions

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

• Review source documents to ensure the accuracy of CRF and other collected data

• Manage clinical registries and conduct feasibility assessments

• Complete Serious Adverse Event reports, including narratives and follow-ups

• Review CRFs and generate as well as address queries within data management systems

• Support the training of new staff through co-monitoring efforts

• Coordinate specific clinical projects in the capacity of a Local Project Coordinator

• Serve as a local client liaison when designated

• Execute additional tasks assigned by management

⛳️ Requirements

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

• Minimum of 1 year of experience in Clinical Monitoring

• Experience in Phase I trials

• Ability to thrive in a dynamic environment with stringent study protocols and timelines

• Flexibility to adjust to rapidly changing priorities

• Strong teamwork and interpersonal skills

• Proficiency in a technology-driven electronic data environment

• Capability to sit for extended periods and operate a vehicle safely

• Skill in repetitive hand movements and the ability to perform quick, simple motions with fingers, hands, and wrists

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

• Competence in accessing and utilizing various computer software

• Capacity to lift and carry between 15-20 lbs

• Regular and reliable attendance is required

• Willingness to work varied hours as needed

🏝️ Benefits

• Flexible remote work options

• 40-50% overnight travel required

• Occasional travel, both domestic and international

• Continuous acceptance of applications