Clinical Research Associate

• Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards
• Perform all aspects of study site monitoring, including 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
• Ensure integrity of data submitted on Case Report Forms (CRFs) and other data collection tools
• Monitor data for missing or implausible data
• Manage clinical trial registries according to project plans
• Undertake feasibility work when requested
• Complete Serious Adverse Event (SAE) reporting, including reports, narratives, and follow-up
• Perform independent 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, with supervision if applicable
• Act as a local client contact as assigned
• Perform other duties assigned by management

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 2 years of Clinical Monitoring experience
• Ability to travel overnight 60% of the time
• Comfortable working in a fast-paced, protocol-driven environment
• Ability to adapt to constantly changing priorities
• Teamwork and people skills
• Comfort working in a technology-based electronic data environment
• Ability to sit for extended periods and operate a vehicle safely
• Repetitive hand movement of both hands and ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck
• Ability to access and use a variety of computer software
• Ability to lift and carry objects, including luggage and laptop computer, weighing 15–20 lbs maximum
• Regular and consistent attendance
• Varied hours may be required

Demonstrates expertise in Clinical Monitoring and Study Site Management, ensuring compliance with regulatory requirements and maintaining data integrity throughout clinical trials. Proficient in managing clinical trial registries and conducting training for new staff in a fast-paced environment.

• Clinical Monitoring Experience
• Regulatory Compliance
• Data Integrity Management
• Study Site Management
• Informed Consent Verification

• Clinical Trial Monitoring
• Case Report Form (CRF) Review
• Serious Adverse Event (SAE) Reporting
• Data Management Systems
• Feasibility Assessment

• Teamwork
• Adaptability
• Communication Skills

• Nursing Licensure
• Certification in Allied Health Profession

• Clinical Trials
• Study Site Monitoring
• Project Plans
• Vendor Liaison
• Protocol-Driven Environment

• Electronic Data Environment
• Data Collection Tools