Clinical Trials Coordinator II - Data & Compliance Lead

McLaren Health Care; Detroit (MI); On-site; USD 55,000 - 75,000; 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 (CTO). You will manage independent assignments and provide excellent customer support and guidance in the clinical trials arena.

Responsibilities include ensuring all study requirements are met and documented, maintaining logs and the CTO Oncore database, designing data coordination systems, coordinating site visits, and supporting patient and protocol

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.
• Coordinates clinial trials onboarding for physicians, non-physicians providers, clinical staff, and clinical trials office personnel.
• Maintains the National Cancer Institute's (NCI) registrations to support clinical trials participation and ongoing compliance.
• Provides operational and administrative support of KCI CTO electronic clinical research system.

Skills

Study coordination

Data management

Regulatory knowledge

Communication

Education

Bachelor’s degree or equivalent

Clinical research certification (preferred)

Tools

Oncore

Job description

McLaren Health Care in Detroit, MI is seeking a study coordinator/data management/regulatory specialist to support the Clinical Trials Office (CTO). You will manage independent assignments and provide excellent customer support and guidance in the clinical trials arena.

Responsibilities include ensuring all study requirements are met and documented, maintaining logs and the CTO Oncore database, designing data coordination systems, coordinating site visits, and supporting patient and protocol