Senior Clinical Research Coordinator

Department

BSD MED - Emergency Medicine

About the Department

The Emergency Trials Unit (ETU), a team within the section of Emergency Medicine, enrolls patients from the Emergency Department in industry and grant funded research studies and trials. In addition, we partner with other departments, such as Neurology and Trauma, in their clinical research studies. David Beiser, is the Director of our team and Sara Roy is the Manager. Dr. Marina Del Rios has recently joined the faculty, and has her own clinical research portfolio which is being integrated into the greater clinical research infrastructure as well.

Job Summary

The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the Sr CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. The Sr CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, the Sr. CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.

Responsibilities

• Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.

• Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.

• Serve as a resource person or act as a consultant within area of clinical expertise.

• Act as a leader within the department/unit through improving clinical research practice and serving as a resource.

• Maintain working knowledge of current protocols, and internal SOPs.

• Be accountable for high standards of clinical research practice and assist in the development of accountability in others.

• Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

• Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.

• Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

• Provide Investigators with guidance regarding protocol requirements.

• Maintain regulatory documentation.

• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.

• Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

• Accountable for all tasks in complex clinical studies.

• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

• Advanced degree.

Experience:

• Experience coordinating multiple and a variety of studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP).

Preferred Competencies

• Develop a program and a team.

• Excellent time management skills and ability to work independently.

• Develop research program and work strategically with Principal Investigator(s).

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