Clinical Research Associate - Regional

Clinical Research Associate - Regional

We are seeking a dedicated Clinical Research Associate who will collaborate with various functional managers and study teams to ensure effective study operations planning, site management, and monitoring. The ideal candidate will be based in Arizona, Utah, Colorado (Denver), or Illinois (Chicago) to facilitate ease of travel.

Responsibilities

• Conduct and report onsite and remote monitoring visits including SQV, SIV, IMV, and COV.
• Perform CRF review, source document verification, and query resolution.
• Manage site communication and act as a point of contact for clinical sites and vendors.
• Assist in the development and amendment of study-related manuals and documentation.
• Establish and maintain excellent working relationships with stakeholders.
• Support project planning activities to meet recruitment targets and deliver high-quality data.
• Ensure timely reporting and documentation of Adverse Events, Serious Adverse Events, and Product Quality Complaints.
• Maintain and update trial management systems including TMF and ISF.
• Participate in Investigator Meetings and training sessions as needed.
• Perform independent field monitoring including site assessments, initiation, interim, and closeout visits.
• Assist in planning clinical supplies, ensuring product availability, and completing Site Product Accountability.
• Contribute to process improvement, training, and mentoring of study staff.

Essential Skills

• 5 years of experience as a Clinical Research Associate with onsite risk-based monitoring.
• Experience working in pulmonary therapeutic areas.
• Completed undergraduate degree in a scientific discipline or nursing.
• 5+ years of field monitoring and study management in biotech/pharma.
• 3+ years of experience in relevant therapeutic areas.
• Working knowledge of ICH-GCP and FOA regulations.
• Proficiency in MS Office, electronic databases, and Clinical Research tools and systems.
• Excellent interpersonal, time management, and communication skills.

Additional Skills & Qualifications

• Experience in hypertension, cardio, pulmonary, transplant, and orphan drugs is a plus.
• Ability to work independently and collaboratively within a team.
• Willingness to travel as needed.

Work Environment

This position involves remote-based monitoring with travel required 75-80% of the time. Ideal candidates will be located in Utah, Arizona, Chicago, or Denver to support travel needs. The role offers long-term project involvement with unique studies and strong organizational support.

Job Type & Location

This is a Contract position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $85.00 - $85.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 16, 2026.