Post-Approval Research Compliance Lead

Kapili Services, LLC; Silver Spring (MD); In loco; USD 88.000 - 99.000; Tempo pieno

Vantaggi offerti da questo lavoro

401K plan with company match

Medical, dental, disability, and life

Tuition reimbursement

Paid time off

11 paid holidays

Descrizione del lavoro

Kapili Services, LLC invites applications for a Post Approval Compliance Monitor to support the WRAIR HSPB in Silver Spring, MD. The role focuses on developing monitoring plans, conducting regulatory file reviews, and delivering timely training to investigators and staff.

Ideal candidates will have a Bachelor's degree and at least 2 years in clinical research monitoring, with strong knowledge of FDA regulations and documentation practices.

Competenze

• Bachelor's degree in Biomedical Science, Public Health, Clinical Research, Regulatory Affairs, Psychology, Biology, or related life science disciplines.
• Minimum two (2) years of experience in clinical research monitoring, human subjects research oversight, IRB operations, or regulatory compliance.
• Experience performing monitoring visits, audits, or postapproval reviews of human subjects research.
• Ability to track and meet multiple deadlines consistently.
• Experience presenting training or education on research compliance topics.
• Excellent understanding of FDA regulations relating to human subjects protections, ethical research principles, and compliance practices.
• Strong analytical and document review skills with high attention to detail.
• Ability to work independently, manage multiple priorities, and maintain strict timelines.
• Skilled in presenting regulatory requirements and compliance expectations clearly.

Mansioni

• Monitoring Program Development: Develop a comprehensive monitoring plan for WRAIR and forward labs; deliver within three months and update annually.
• Routine and ForCause Monitoring: Conduct routine/for-cause monitoring; ensure IRB requirements are applied.
• Reporting and Documentation: Draft monitoring reports; provide drafts within ten business days of each visit.
• Regulatory File Reviews: Conduct weekly reviews of HSPB files; update within five business days; manage delays.
• Training and Education: Provide training on human subjects protection and monitoring best practices; develop training materials.

Conoscenze

Regulatory compliance

IRB operations

Monitoring visits

Report writing

Time management

Training

Formazione

Bachelor's degree

Master's degree preferred

Descrizione del lavoro

Kapili Services, LLC invites applications for a Post Approval Compliance Monitor to support the WRAIR HSPB in Silver Spring, MD. The role focuses on developing monitoring plans, conducting regulatory file reviews, and delivering timely training to investigators and staff.

Ideal candidates will have a Bachelor's degree and at least 2 years in clinical research monitoring, with strong knowledge of FDA regulations and documentation practices.