Clinical Research Coordinator II — Data & Compliance Specialist

McLaren Health Care; Detroit (MI); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Full-time schedule

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 manage data, ensure regulatory compliance, and provide expert guidance in the clinical trials arena.

Responsibilities include ensuring study requirements are met, maintaining logs and the Oncore database, designing data workflows, coordinating site visits, and supporting queries.

Qualifications

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

Responsibilities

• Assure all study requirements are met and documented and meet both internal and external regulations in accordance with protocol guidelines.
• Maintain logs, including tracker submissions and update the CTO Oncore database in a timely manner according to CTO SOPs.
• Design systems for coordinating, compiling and submission of data; design workflow processes and participate in quality assurance measures; coordinate site visits.
• Manage all patient and/or protocol data as assigned and respond to queries in a timely fashion.
• Schedule and participate in monitoring visits and participate in multidisciplinary team program meetings as required.

Skills

Data management

Regulatory affairs

Clinical research

Education

Bachelor’s degree

Clinical research certification preferred

Tools

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 manage data, ensure regulatory compliance, and provide expert guidance in the clinical trials arena.

Responsibilities include ensuring study requirements are met, maintaining logs and the Oncore database, designing data workflows, coordinating site visits, and supporting queries.