Clinical Research Associate

• Provide a high standard of care for participants in clinical trials and respond to emergency situations according to clinical research standards
• Perform all aspects of study site monitoring, including routine monitoring and close-out of clinical sites
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors and perform other assigned duties
• 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 source data for missing or implausible information
• Manage registries according to project plans and undertake feasibility work when requested
• Complete Serious Adverse Event (SAE) reporting, including reports, narratives, and follow-up
• Independently review CRFs and generate and resolve queries in 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 when applicable
• Act as a local client contact when assigned
• Travel frequently to client and site locations, including occasional domestic and international travel
• 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
• 60% 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 environment and enter data electronically
• 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 upper body and neck
• Ability to access and use a variety of in-house and off-the-shelf computer software
• Ability to lift and carry objects, luggage, and laptop computer weighing up to 15-20 lbs
• 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. Proficient in managing clinical trials, including monitoring, training, and liaising with vendors while adapting to fast-paced environments.

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

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

• Teamwork
• Adaptability
• Communication Skills

• Nursing Licensure
• Certification in Allied Health Profession

• Clinical Research Standards
• Study Protocol
• Project Plans
• Vendor Liaison
• Monitoring Procedures

• Data Management Systems
• Electronic Data Entry Software