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.
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.
Supports investigator development by guiding new and established investigators through the clinical trials process.
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.
Requirements
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.
Qualifications
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.
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.
Skills & Abilities
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.
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.
Benefits
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program