Clinical Research Coordinator II

McLaren Health Care; Detroit (MI); Sur place; USD 42 000 - 64 000; Plein temps

Avantages offerts par ce poste

Equal Opportunity Employer

Full-time schedule

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Data management

Regulatory affairs

Clinical research

Formation

Bachelor’s degree

Clinical research certification preferred

Outils

Oncore database

Description du poste

The McLaren system includes 12 hospitals across the state, ambulatory surgery centers, imaging centers, a 730-member employed primary and specialty care physician network, commercial and Medicaid HMOs covering more than 242,000 Michigan lives, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network, and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, a National Cancer Institute-designated comprehensive cancer center. McLaren has 20,000 full-, part-time and contracted employees and more than 93,000 network providers throughout Michigan.

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

Additional Information

• Schedule: Full-time
• Daily Work Times: 8am-4:30pm
• On Call: No

McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status, national origin, disability, genetic information, height or weight, protected veteran or other classification protected by law.

McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status,national origin, disability, genetic information, height or weight, protected veteran or other classificationprotected by law.