Clinical Research Coordinator II

mclarenhlth; Detroit (MI); On-site; USD 65,000 - 85,000; Full time

Job summary

McLaren Health Care is seeking a Study Coordinator/Data Management/Regulatory Specialist to support the Clinical Trials Office (CTO). You will ensure study requirements are met, logs are maintained, and data are coordinated and submitted in compliance with protocols and regulations.

The role involves managing data across systems, providing excellent customer support, and participating in monitoring visits and team meetings.

Qualifications

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

Responsibilities

• Assure study requirements are met and documented per protocol and regulations.
• Maintain logs and update the CTO Oncore database timely.
• Design systems for coordinating, compiling and submitting data and participate in QA measures.
• Manage patient and/or protocol data and respond to queries timely.
• Schedule and participate in monitoring visits and multidisciplinary program meetings.

Skills

Customer support

Communication

Documentation

Education

Bachelor's degree or equivalent

Clinical certification preferred

Tools

Oncore database

Job description

Provide study coordinator/data management/regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment, providing excellent customer support and guidance in the clinical trials arena.

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.

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

Equal Opportunity Employer of Minorities/Females/Disabled/Veterans