Clinical Trials Operations Lead

CPC Clinical Research; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

CPC Clinical Research is seeking an experienced Clinical Operations Manager I to oversee site identification, regulatory submissions, and site performance across trials. The role requires strong organizational skills and the ability to adapt to changing project needs.

You will manage cross-functional teams, ensure quality deliverables, and drive timely project milestones while maintaining sponsor and CPC alignment on scope and budget.

Qualifications

• Nursing degree or BA/BS in a field of science is required or equivalent knowledge/experience.
• 3 years of clinical research experience is required, or 1 year as a Research Assistant is required.
• Thorough knowledge of Good Clinical Practice and FDA/ICH regulations for clinical drug trials.

Responsibilities

• Manage site identification and evaluation.
• Develop or review essential study documents including protocols, CRFs and source documents.
• Review site regulatory documents for CPC SOPs and applicable laws and guidelines.
• Prepare central IRB submissions and resolve IRB issues.
• Manage site enrollment, subject tracking and payments.
• Assist with monitoring of project deliverables and timelines.
• Develop and distribute project documents (reports, letters, meeting minutes).
• Identify training needs and ensure completion of training documentation.

Skills

Nursing degree or BA/BS in a science

3 years of clinical research exp

GCP & FDA/ICH knowledge

Clinical site startup experience

Education

Nursing degree or BA/BS in a scientific field

Job description

CPC Clinical Research is seeking an experienced Clinical Operations Manager I to oversee site identification, regulatory submissions, and site performance across trials. The role requires strong organizational skills and the ability to adapt to changing project needs.

You will manage cross-functional teams, ensure quality deliverables, and drive timely project milestones while maintaining sponsor and CPC alignment on scope and budget.