Clinical Research Associate

Job Description

Job Description

Description:

Status : Full Time, Exempt

Travel : >50%

Reports To : Director of Clinical Operations

Location : Central to East Coast Territory

Position Summary

The Clinical Research Associate (CRA) conducts monitoring and site management activities to support study execution and ensure clinical sites adhere to protocol requirements, applicable regulatory requirements, and sponsor guidelines. The CRA supports the Clinical Operations Team in implementing study plans and executing delegated monitoring and site management activities. This role supports accurate, complete, and timely data reporting while ensuring compliance with Company Standard Operation Procedures (SOP), Good Clinical Practice (GCP), and FDA regulations. The CRA is responsible for executing delegated monitoring and study management activities to support achievement of assigned study milestones and departmental expectations while managing associated budgets, as applicable.

Job Duties/Responsibilities

• Conduct site monitoring visits, including site feasibility, initiation, routine monitoring, and close-out visits, in accordance with SOP, protocol requirements, GCP and applicable regulatory requirements.
• Deliver protocol-specific and study-related training to assigned sites and maintain consistent communication to address study expectations, questions, and emerging issues.
• Perform source data review and verification to ensure accuracy and completeness of clinical trial data.
• Assess site compliance with the protocol, GCP, and applicable regulations by reviewing study conduct, documentation practices, and data quality; escalate significant findings when necessary.
• Monitor overall study progress at assigned sites by reviewing enrollment activity, CRF completion, EDC entry, and query resolution.
• Escalate site compliance issues, protocol deviations, and data quality concerns to the CRM/Senior CRM as appropriate.
• Verify that essential regulatory documents are collected and filed appropriately in the Trial Master File (TMF) and confirm that the Investigator Site File (ISF) is maintained in accordance with GCP and local regulatory standards.
• Document monitoring activities and site interactions through timely visit reports, follow-up correspondence, and action plans to ensure resolution of findings.
• Collaborate with cross-functional study team members to support effective study execution and issue resolution.
• Contribute to the development and implementation of site-level recruitment plans when applicable.
• Conduct site close-out visits and ensure resolution of outstanding data queries, regulatory reconciliation, and completion of required site close-out activities.
• Provide support during site start-up activities as needed
• Support regulatory document management activities, including tracking, and filing of required study documentation.
• Embodies the Company’s purpose and shared values building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned.

Requirements:

• Bachelor’s degree in a scientific or health-related discipline preferred.
• 1-2 years of related experience in clinical research.
• Experience as a Clinical Research Coordinator(CRC) or Sponsor CRA preferred.
• Experience with clinical site data collection and/or monitoring preferred.
• Oncology clinical research experience strongly preferred.
• GCP training and certification.
• Working knowledge of computer systems and standard business applications.
• Strong verbal and written communication skills.
• Excellent organizational skills along with strong attention to detail and accuracy.
• Ability to work independently while also collaborating effectively with cross-functional teams.
• Proficiency in Microsoft office applications (SharePoint, Word, Excel and PowerPoint).
• Flexibility to work varied schedules as needed.
• Satisfactorily pass comprehensive background screening.

Physical Demands/Working Conditions

• Works in a variety of environments (office, home, hotel, events, hospital).
• Frequent travel using a variety of transportation methods for work, meetings, events, trainings, etc.
• Occasional to frequent overnight travel depending upon territory needs.
• Combination of a stationary role with frequent movement from place to place.
• Frequent use of a computer, keyboard, mouse, monitor and other office/sales equipment.
• Frequently picks up, carries, and moves items up to 50 lbs.
• Some evening and weekend work depending upon workload.
• 60-70% travel required for work, events, and training.