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Brio Group · Durham, North Carolina
Clinical Research Associate (CRA) – 1099 Independent Contractor
Department:
Clinical Operations
Contract Type:
1099 Independent Contractor
Workload:
Fully Allocated (40+ Hours per Week)
Travel:
Approximately 70–75%
On-Site Monitoring Requirement:
8 Days per Month
Therapeutic Areas:
Oncology and/or Gastroenterology
United States
Position Overview
An established clinical research organization is seeking an experienced Clinical Research Associate (CRA) to support clinical trial activities across the United States on a 1099 independent contractor basis.
Key
Clinical Monitoring and Site Management
Prepare for, conduct, and document site selection, initiation, routine monitoring, and closeout visits.
Independently manage assigned investigator sites and ensure compliance with study protocols, GCP, and applicable regulatory requirements.
Monitor clinical trial progress, patient recruitment and enrollment, data quality, and study timelines.
Identify, document, escalate, and follow up on site issues, protocol deviations, and corrective and preventive actions.
Review monitoring reports and ensure timely resolution of outstanding action items.
Support Phase I–III clinical trials.
Study Start-Up and Regulatory Support
Coordinate the collection, review, and maintenance of essential regulatory documents.
Participate in site feasibility, qualification, and selection activities.
Facilitate site activation, contract execution, and budget processes.
Support investigator site payment tracking and follow-up.
Maintain accurate study documentation and site-level tracking systems.
Communication and Collaboration
Serve as a primary point of contact for assigned investigator sites.
Collaborate with clinical project teams, sponsors, vendors, and internal support functions.
Deliver training to investigators and site staff on study protocols, procedures, and requirements.
Support project team training and investigator meetings.
Communicate site progress, recruitment challenges, risks, and study-related issues promptly.
Quality Assurance and Compliance
Ensure monitoring activities and documentation meet applicable regulatory, GCP, protocol, and sponsor requirements.
Participate in quality control activities, audits, and inspections as needed.
Support audit preparation, follow-up, and resolution of findings.
Maintain accurate and timely information in study-specific and corporate tracking systems.
Contribute to continuous improvement of clinical monitoring and site management processes.
Required
College or university degree in Life Sciences or an equivalent combination of education, training, and relevant experience.
At least 5 years of independent on-site clinical monitoring experience in the United States.
Experience conducting all major types of monitoring visits, including site selection, initiation, routine monitoring, and closeout.
Established LLC and ability to provide services through the LLC as an independent contractor.
Full professional working proficiency in English.
Proficiency in Microsoft Office applications.
Excellent organizational, communication, collaboration, and problem-solving skills.
Ability to manage multiple priorities and work independently in a dynamic clinical research environment.
Valid driver's license and willingness to travel extensively throughout the United States.
Workload and Travel
Fully allocated engagement requiring 40+ hours per week.
Target of eight on-site monitoring days per month.
Travel to assigned clinical research sites throughout the United States.
Independent contractor engagement through the contractor's LLC.
Details
| Company | Brio Group |
| Location | Durham, North Carolina |
| Type | FULL TIME |
| Niche | Business services agents not elsewhere classified |