Clinical Research Site Monitor

NSABP Foundation Inc.; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

NSABP Foundation Inc. is seeking a Clinical Research Coordinator to oversee site operations and ensure data integrity in support of breast and colorectal cancer research. This fully remote role involves collaboration with clinical staff and compliance with regulatory standards, making it vital for the success of various studies.

Qualifications

• Experience with clinical trials preferred.
• Familiarity with electronic TMF, CRF, and CTMS systems preferred.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Participate in developing the overall clinical plan.
• Document activities using templated communication forms.
• Ensure compliance with the Clinical Monitoring Plan.

Skills

Strong software skills

Excellent verbal communication

Excellent written communication

Organizational skills

Ability to prioritize multiple tasks

Job description

Get AI-powered advice on this job and more exclusive features.

This is a fully remote contracted role intended to be the “external face” of the organization at NSABP sites, working with principal investigators and research staff. The role acts as a bridge between site operations and NSABP operations to ensure data integrity, patient safety, and regulatory compliance. It supports breast and colorectal cancer research and the successful execution of clinical protocols across multiple sites, ensuring adherence to regulatory and contractual standards.

ESSENTIAL FUNCTIONS

1. Participate in developing the overall clinical plan, including site initiation visits (SIV), interim monitoring, site management activities, and close-out visits, including investigational product management.
2. Document activities using templated communication forms.
3. Ensure compliance with the Clinical Monitoring Plan (CMP) for each study.
4. Act as a resource for sites and investigators to address questions, respond to queries, identify gaps, and assist with mitigation planning and implementation.
5. Collaborate with clinical research organizations and centralized services such as clinical laboratories.
6. Participate in study-specific training as required.
7. Coordinate with data management regarding CRF development, completion, deviations, and query management.
8. Identify potential investigators and clinical sites.
9. Ensure the security and compliance of all documents related to active and archived projects.
10. Perform investigational product inventory, reconciliation, storage, and security assessments, including dispensing practices and documentation.
11. Review Investigator Site Files (ISF) with the Trial Master File for accuracy, completeness, and timeliness.
12. Verify informed consent processes and documentation.
13. Collaborate with NSABP Operations staff on site and study management issues.
14. Coordinate protocol review and approval, including submissions to regulatory agencies.
15. Collect and review regulatory documents for content and accuracy.
16. Ensure compliance with the specific scope of work and contractual tasks.
17. Maintain site data integrity, including background checks and EMR access policies.
18. Attend all scheduled operations and study-specific meetings.
19. Perform other related duties as assigned.

OTHER RESPONSIBILITIES

• Knowledge of randomized clinical trial principles and procedures.
• Understanding of federal and state regulations, including ICH-GCP guidelines.
• Familiarity with infrastructure and operational aspects of patient accrual and site management.

EXPERIENCE/SKILLS

• Strong software skills and comfort with multiple programs.
• Experience with clinical trials preferred.
• Familiarity with electronic TMF, CRF, and CTMS systems preferred.
• Excellent verbal, written, and organizational skills with a team-oriented approach.
• Ability to prioritize multiple tasks and meet deadlines in a dynamic environment.
• Proficiency in Microsoft Office Suite.
• Ability to travel up to 85% of the time.

Seniority level

• Entry level

Employment type

• Full-time

Industry

• Research Services

This job is currently active and accepting applications.