Clinical Trials Data & Regulatory Coordinator

McLaren Health Care; Detroit (MI); On-site; USD 52,000 - 68,000; Full time

Job summary

McLaren Health Care in Detroit, MI is seeking a Study Coordinator/Data Management/Regulatory Specialist to support the Clinical Trials Office. You will ensure study requirements are met, manage data, and provide timely guidance to trial teams.

Responsibilities include maintaining logs and tracking submissions, updating the CTO Oncore database, designing data coordination workflows, coordinating site visits, and responding to queries. A Bachelor’s degree is required.

Qualifications

• Bachelor’s degree required or equivalent combination of education and experience.
• Clinical research certification preferred.
• Medical and/or science experience preferred.

Responsibilities

• Provide study coordinator, data management and regulatory support to the CTO.
• Assure all study requirements are met and documented per protocol guidelines.
• Maintain logs, tracker submissions, and update the CTO Oncore database.
• Design systems for coordinating, compiling and submitting data; design workflows and QA.
• Schedule and participate in monitoring visits and cross-functional team meetings.

Skills

Customer support

Data management

Regulatory compliance

Problem solving

Education

Bachelor's degree

Tools

CTO Oncore database

Job description

McLaren Health Care in Detroit, MI is seeking a Study Coordinator/Data Management/Regulatory Specialist to support the Clinical Trials Office. You will ensure study requirements are met, manage data, and provide timely guidance to trial teams.

Responsibilities include maintaining logs and tracking submissions, updating the CTO Oncore database, designing data coordination workflows, coordinating site visits, and responding to queries. A Bachelor’s degree is required.