Contract Clinical Research Associate (Durham)

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

Location: 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 Responsibilities

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 Qualifications

• 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.
• Experience monitoring Phase I–III clinical trials.
• Clinical trial monitoring experience in oncology and/or gastroenterology.
• Experience working as an independent consultant under a 1099 arrangement.
• 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 Requirements

• Fully allocated engagement requiring 40+ hours per week.
• Approximately 70–75% travel, depending on study and site requirements.
• 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.