Clinical Trials Operations Leader

Astera Cancer Care; Nashville (TN); On-site; USD 90,000 - 140,000; Full time

Job summary

Tennessee Oncology, a leading community-based cancer care network based in Nashville, seeks a Clinical Research Regulatory Manager to oversee the Research Department's regulatory activities. You will guide CRCs, implement training programs, and ensure compliance with FDA/ICH guidelines.

Join a mission-driven team dedicated to high-quality cancer care and research across multiple community locations, with opportunities for professional development and impact.

Qualifications

• Bachelor's Degree or equivalent combination of education and experience required.
• Four years of relevant experience required.
• Certification in clinical research coordination from ACRP or SOCRA preferred.

Responsibilities

• Efficiently manages regulatory aspects of the Research Department.
• Provides leadership in development and implementation of regulatory strategies for clinical research missions.
• Stays up to date with new SOPs and regulations and aligns training accordingly.
• Serves as preceptor for new research staff members.
• Maintains regulatory documents according to policies and regulations.
• Liaises with sponsor staff and prepares for audits.

Skills

Verbal communication

Written communication

Organization

Follow-up

Multi-tasking

Trial protocols

Teamwork

MS Office

Bilingual EN/ES

Education

Bachelor's Degree

4 years experience

ACRP/SOCRA cert preferred

Tools

Microsoft Office

Job description

Tennessee Oncology, a leading community-based cancer care network based in Nashville, seeks a Clinical Research Regulatory Manager to oversee the Research Department's regulatory activities. You will guide CRCs, implement training programs, and ensure compliance with FDA/ICH guidelines.

Join a mission-driven team dedicated to high-quality cancer care and research across multiple community locations, with opportunities for professional development and impact.