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BSD MED - Pulmonary - Clinical Research Staff

About the Department

The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.

Job Summary

The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Section Administrator and/or Clinical Research Manager within the Section of Pulmonary/Critical Care Medicine in the Department of Medicine. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, 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.

Responsibilities

• Leads within the department/unit through improving clinical research practice and serves as a resource to others.
• Works with the PIs, department, sponsors, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
• Assists with or plans and implements the clinical study\'s goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.
• Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
• Serves as a resource person or acts as a consultant within area of clinical expertise.
• Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.
• Maintains working knowledge of current protocols, and internal SOPs.
• Accountable for high standards of clinical research practice and assists in the development of accountability in others.
• Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
• Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.
• Prepares, submits, and assists Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Provides Investigators with guidance regarding protocol requirements.
• Maintains regulatory documentation.
• Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Provides direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
• Attends continuing education and training opportunities relevant to job duties.
• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.
• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writi g protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
• 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.

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Work Experience:

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

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Certifications:

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Preferred Qualifications

Education:

• Master\'s degree.

Experience:

• Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).

Licenses and