Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct site monitoring visits, which encompass feasibility, initiation, routine monitoring, and close-out visits.

• Provide protocol-specific and study-related training to designated sites.

• Maintain ongoing communication with sites regarding study expectations, inquiries, and emerging issues.

• Execute source data review and verification tasks.

• Evaluate site compliance with protocols, Good Clinical Practice (GCP), and relevant regulations.

• Oversee enrollment, Case Report Form (CRF) completion, Electronic Data Capture (EDC) entry, and query resolution.

• Raise awareness of compliance issues, protocol deviations, and concerns regarding data quality.

• Confirm the collection and organization of essential regulatory documents in the Trial Master File (TMF).

• Ensure that Investigator Site Files are maintained according to GCP and local regulations.

• Record monitoring activities through visit reports, follow-up correspondence, and action plans.

• Collaborate with cross-functional study team members to facilitate study execution and resolve issues.

• Contribute to the development of site-level recruitment strategies.

• Conduct site close-out visits and address outstanding queries and regulatory reconciliations.

• Assist with site start-up activities.

• Support the tracking and filing of regulatory documents.

• Adhere to company policies and procedures, ensuring the protection of PHI/ePHI.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in a scientific or health-related field is preferred.

• 1–2 years of pertinent experience in clinical research.

• Experience as a Clinical Research Coordinator (CRC) or Sponsor Clinical Research Associate (CRA) is preferred.

• Familiarity with clinical site data collection and/or monitoring is preferred.

• Oncology clinical research experience is strongly preferred.

• GCP training and certification are required.

• Proficient understanding of computer systems and standard business applications.

• Excellent verbal and written communication skills.

• Outstanding organizational skills with a keen attention to detail and accuracy.

• Capability to work independently while effectively collaborating with cross-functional teams.

• Proficiency in Microsoft Office applications, including SharePoint, Word, Excel, and PowerPoint.

• Willingness to work flexible schedules.

• Must successfully pass a comprehensive background screening.

• Ability to travel frequently, with occasional to frequent overnight travel required.

• 60–70% travel is expected.

• Ability to frequently lift, carry, and move items weighing up to 50 lbs.

• Some evening and weekend work may be necessary depending on workload.

🏝️ Benefits

• Exempt status.

• Remote work arrangement.

• GCP training and certification.

• Work environments may include office, home, hotel, events, and hospital settings.

• Company-paid travel for work-related meetings, events, and training sessions.