Oncology Clinical Trials Operations Administrator

Toledo Clinic; Maumee (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Toledo Clinic is seeking a Research Administrator to support administrative and regulatory tasks for clinical trials, from startup through closeout. You will assist with IRB submissions, regulatory documents, ISFs, and binder maintenance, coordinating with CROs and sponsors.

The role also involves supporting the Sr. Director, Research Site Operations in feasibility surveys, PI oversight documentation, and day-to-day program operations to ensure compliance and timely study progression.

Qualifications

• Minimum 5 years of administrative experience in research.
• Knowledge of GCP (Good Clinical Practices).
• Strong team-oriented, results driven, and collaborative style.
• Certification in Human Subjects Protection and GCP (within 30 days of hire).
• Strong organizational and communication skills.
• Bachelor’s degree or equivalent experience.

Responsibilities

• Oversee administrative and regulatory processes for clinical trials from start-up to closeout, including IRB submissions.
• Prepare and collect regulatory documents and ISF, Pharmacy, and Lab binder maintenance.
• Prepare IRB submissions, amendments, and informed consent forms as required.
• Assess safety reporting requirements and support PI oversight with study-wide documentation.
• Assist Sr. Director, Research Site Operations and ROA in day-to-day program operations and feasibility surveys.
• Document weekly PI Oversight meeting topics and maintain study logs and spreadsheets.
• Coordinate sponsor communications for monitoring visits and site liaison duties.

Skills

GCP knowledge

Strong organizational skills

Strong communication skills

Collaborative teamwork

Regulatory awareness

Education

Bachelor’s degree or equivalent experience

Master’s degree in health-related field (preferred)

Job description

Toledo Clinic is seeking a Research Administrator to support administrative and regulatory tasks for clinical trials, from startup through closeout. You will assist with IRB submissions, regulatory documents, ISFs, and binder maintenance, coordinating with CROs and sponsors.

The role also involves supporting the Sr. Director, Research Site Operations in feasibility surveys, PI oversight documentation, and day-to-day program operations to ensure compliance and timely study progression.