Manager Clinical Trials Research

Oversees clinical research, including industry and federally-sponsored clinical trials cooperative group studies, from initiation to completion in assigned service line(s) at the regional level, with a focus on Northern Wisconsin with majority at Aurora BayCare.

Leads and develops a diverse team of research professionals responsible for the conduct of clinical trials research across multiple sites, including hospital and clinic settings.

Responsible for efficient flow of clinical trial research including study feasibility, selection, start-up, conduct and close-out and for achieving performance targets on clinical trials to further establish Advocate Aurora Health as a premier research destination for patients and clinical trial sponsors.

Major Responsibilities :

Develops working relationships and collaborates with clinical and research leadership to align internal strategies, enhance the institution's research capabilities and reputation, and establish best practices.

Cultivates, supports, and enhances collaborative and productive relationships with clinician investigators and industry and government sponsors.

Partners with leadership, research support services and investigators to provide financial oversight related to research study budgets and trial financial performance.

Reviews study budgets and maintains fiscal accountability for studies within the portfolio as well as operating budgets.

Establishes effective, efficient, high quality and valued clinical trial research through quantifiable and standard metrics and works with clinical trial leadership to implement mechanisms to drive measurable performance improvement.

Partners with leaders in the Clinical Trials Office and Research Services to support high integrity, safe, compliant and cost-effective clinical trial operations.

Monitors and ensures research is compliant with applicable regulations and policies of the research institute, the Research Subjects Protection Program (RSPP), and other related departments, programs, and governmental agencies.

Updates and develops existing or new program policies and procedures to ensure operational and compliance needs are met.

Manages communications related to research studies, quarterly metrics, safety / compliance issues, audit findings, etc.

to keep investigators and research team members informed and aligned.

• Partners with internal and external stakeholders to develop new business relationships to augment research opportunities.
• Partners with analytics, research systems, and other groups to develop, facilitate, implement, use appropriate research systems (e.

g. clinical trial management systems) to ensure efficient research operations.

• 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 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.

Licensure, Registration, and / or Certification Required :

• Clinical Research Coordinator (CCRC) certification issued by the Association of Clinical Research Professionals (ACRP) when eligible needs to be obtained within 1 year, or
• Clinical Research Professional (CCRP) certification issued by the Society of Clinical Research Associates (SOCRA) needs to be obtained within 1 year.

Education Required :

• Bachelor's Degree in Nursing, or
• Bachelor's Degree in Health Science, or
• Bachelor's Degree in Life Science or related field.

Experience Required :

Typically requires 5 years of experience in clinical trials research. Includes 3 years of management experience in leading a team.

Knowledge, Skills & Abilities Required :

• Ability to problem solve and facilitate consensus in a group environment
• Knowledge of regulations and guidelines consistent with conduct of clinical trials including but not limited to ICH- GCP guidelines, Code of Federal Regulations, AAHRP accreditation standards
• Demonstrated knowledge of clinical trials business practices
• Effective communication and leadership skills
• Ability to think critically.
• Ability to organize with attention to detail.
• Ability to handle stress
• Project management skills
• Ability to establish and maintain successful relationships
• Ability to work as a member of a diverse team as well as an independent agent of change

Physical Requirements and Working Conditions :

• Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently during the work shift.
• Must have functional sight and hearing.
• Ability to function in a latex environment.
• Will be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis;

therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary.

• Exposed to a normal office environment.
• Operates all equipment necessary to perform the job.

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.