Director of Clinical Trials Research (Multiple Therapeutic Areas)

Major Responsibilities:
Oversees, develops, monitors, directs and advances clinical trial initiatives and operations necessary to achieve AAH and Advocate Aurora Research Institute (AARI) goals and priorities.

Works closely with the Medical Research Director(s) to cultivate, support, and enhance collaborative relationships with clinician investigators and industry and government sponsors, and to oversee individual protocol review, selection and performance.

Has direct authority for clinical trials operations teams consisting of manager(s), and individual contributors responsible for the conduct of clinical trials research, and for areas that support research excellence and compliance, such as quality, regulatory and education.

Establishes effective, efficient, high quality and valued research activities through quantifiable and standard metrics and develops mechanisms to drive measurable performance improvement. Directs, promotes and supports high integrity, safe, compliant and cost-effective clinical trials operations.

Develops and enhances capabilities, reputation, visibility, awareness and competitive edge of research at AAH.

Leads by example in creating a culture of teamwork, engagement, diversity, equity and inclusion. Performs human resources responsibilities for staff which include interviewing and selection of new team members, promotions, staff development, performance evaluations, compensation changes, resolution of team member concerns, corrective actions, terminations, and overall morale.

Works with senior leadership to develop and recommend operating and capital budgets. Provides financial management and controls expenditures within approved budget objectives.

Supports investigator development by guiding new and established investigators through the clinical trials process.

Accountable for developing strategy for and managing or leading appropriate committees and councils within his/her area(s) of research responsibility.

Accountable for adherence to quality standards, applicable laws and regulations, protocol requirements and federal guidelines pertaining to clinical trial research. Oversees the quality monitoring program for all clinical trial research.

Performs human resources responsibilities for staff which include interviewing and selection of new employees, promotions, staff development, performance evaluations, compensation changes, resolution of employee concerns, corrective actions, terminations, and overall employee morale.

Develops and recommends operating and capital budgets and controls expenditures within approved budget objectives.

Responsible for understanding and adhering to the organization’s Code of Ethical Conduct and for ensuring that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to the organization’s business.

Education/Experience Required:
Master’s Degree in Health Science or related field, or Master’s Degree in Life Science. Typically requires 7 years of experience in clinical research. Typically requires 3 years of management experience in increasingly responsible administrative experience, with evidence of leading and managing clinical research programs and staff, educational activities, and special projects.

Knowledge, Skills & Abilities Required:
Proven experience leading successful clinical research program(s) with measurable success. Manage concurrent complex projects, resources & deadlines. Experience developing/implementing group processes, procedures and collaborations. Demonstrates leadership to ensure high quality, ethical and compliant research and educational conduct. Expert understanding of the conduct of clinical and/or translational research including oversight of human subject research, clinical trials, FDA Regulations, regulatory compliance, and good clinical practices (GCP) principles in research. Possesses knowledge of grant/contract application/award processes, regulations and regulatory process required to conduct human subject research. Is current on relevant literature in health services and clinical research. Understanding of healthcare data, processes, workflows, and clinical research environments. Strong analytical and organizational skills. Ability to work in a complex corporate environment. Excellent communication, problem solving and conflict resolution skills. Ability to communicate effectively at all levels of an organization. Ability to develop and maintain positive, productive working relationships with employees, donors, physicians, corporate leaders, civic/community leaders and other professionals.
None Required.

Physical Requirements and Working Conditions:
Will generally be exposed to rapid-pace and complex office and health setting environments. Must be able to sit for extended periods of time as well as stand and walk throughout each workday. Must be able to operate all equipment necessary to perform the duties of the job. This position requires ability to drive and/or travel to work related meetings/functions and thus is exposed to road and weather hazards during necessary job-related trips. May require travel across the system. This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.