Clinical Research Coordinator II

McLaren; Detroit (MI); On-site; USD 60,000 - 85,000; Full time

Job summary

McLaren in Detroit seeks a Study Coordinator/Data Management/Regulatory Specialist to support the Clinical Trials Office. You will manage independent assignment and provide strong customer support and guidance in the clinical trials arena.

Responsibilities include ensuring study requirements are met and documented per protocol, maintaining logs and updating the CTO Oncore database, designing workflows, managing patient data, and coordinating site visits with a multidisciplinary team.

Qualifications

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

Responsibilities

• Assure all study requirements are met and documented per protocol and regulations.
• Maintain logs and update the CTO Oncore database in a timely manner per SOPs.
• Design systems for coordinating, compiling and submission of data; design workflows and QA measures; coordinate site visits.
• Manage patient/protocol data and respond to queries promptly.
• Schedule and participate in monitoring visits and multidisciplinary team meetings as required.

Skills

Study coordination

Data management

Regulatory support

Quality assurance

Education

Bachelor's degree

Clinical research certification

Tools

CTO 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.

Qualifications

• 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

Additional Information

• Schedule: Full-time
• Requisition ID: 26010318
• Daily Work Times: 8am-4:30pm
• Hours Per Pay Period: 80
• On Call: No
• Weekends: No