Clinical Research Associate 2

Jobtailor; California (MO); On-site; USD 70,000 - 110,000; Full time

Job summary

Jobtailor is seeking a Local Project Coordinator to oversee clinical monitoring and study site management in the United States. You will ensure regulatory compliance, data integrity, and proper training for site staff while coordinating with vendors and sponsors.

The role requires 2 years of clinical monitoring experience, nursing licensure or allied health certification, and the ability to travel 60% overnight.

Qualifications

• University degree or nursing licensure in a related field.
• Minimum of 2 years of clinical monitoring experience.
• Ability to travel overnight 60% of the time.
• Comfortable in a fast-paced, protocol-driven environment.
• Able to adapt to changing priorities and work with teams.

Responsibilities

• Provide high standard of care for participants in clinical trials and respond to emergencies.
• Perform all aspects of study site monitoring including routine monitoring and close-out.
• Maintain study files and conduct pre-study and initiation visits.
• Liaise with vendors and manage study sites per project plans.
• Ensure staff receive proper materials to safely enter patients into the study.
• Verify informed consent procedures and protocol compliance.
• Ensure data integrity of CRFs and other data collection tools.
• Monitor data for missing or implausible values.
• Coordinate clinical projects as Local Project Coordinator under supervision.
• Act as local client contact as assigned.

Skills

Clinical Monitoring

Study Site Management

Regulatory Compliance

Data Integrity

Informed Consent

Education

Nursing Licensure

Allied Health Certification

Tools

Electronic Data Environment

Data Collection Tools

Job description

• 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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

Hard Skills

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

Soft Skills

• Teamwork
• Adaptability
• Communication Skills

Certifications & Qualifications

• Nursing Licensure
• Certification in Allied Health Profession

Industry Keywords

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

Tools & Technologies

• Electronic Data Environment
• Data Collection Tools