Contract Clinical Research Associate

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.