Supervisor, Clinical Trials Research - Cardiology

Oversees the activities of clinical trials, including supervising clinical research caregivers whether employed, contracted, or temporary hires and assisting leadership with the department's business operations and budget. Responsible for integrating internal departments, affiliated physicians and outside customers as they relate to research.

Major Responsibilities:

• Assists the department leadership in the strategic development of research.
• Explores and implements innovative, cost effective approaches to clinical research. Interacts with Research staff to plan and assess ongoing needs in clinical research. Coordinates staff support and organizes, assigns and distributes work.
• Develops patient recruitment plans in collaboration with Research Coordinators. Collaborates with Research Educator in the training and development of the Clinical Research Coordinators.
• Works with leadership and Principal Investigator to determine whether the organization should accept or decline a new clinical study.
• Serves as the primary resource for research process and protocol questions. Develops and maintains a mechanism for quality control of workflows and competencies.
• Provides input to and support of proposed design, implementation, and upgrades of electronic systems. Ensures caregivers are competent users of the electronic systems.
• Reviews and monitors regulatory requirements of a study. Works with internal Research Educator, and assists in any FDA or sponsor audits.
• Develops/edits existing and new departmental policies or standard operating procedures to meet federal and internal compliance needs. Responsible for interpreting and ensuring consistent application of organizational policies.
• Identifies and resolves staff and physician problems/concerns and confers with department leadership as needed.
• Acts as a liaison between the research coordinators, Research Business Services, and the various billing offices to assure billing compliance.
• Performs human resources responsibilities for staff which includes coaching on performance, completes performance reviews and overall staff morale. Recommends hiring, compensation changes, promotions, corrective action decisions, and terminations.
• 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, or
• Clinical Research Professional (CCRP) certification issued by the Society of Clinical Research Associates (SOCRA).

Education Required:

• Bachelor's Degree in Health Science.

Experience Required:

• Typically requires 3 years of experience in research that includes experiences with Federal Drug Administration (FDA) Regulations and ICH and DHHS guidelines.

Knowledge, Skills & Abilities Required:

• Demonstrated leadership skills including management of staff, project management, delegation, team building and problem solving.
• Proficient with advanced word processing, spreadsheet, statistics, data base management, the Internet, and other application software unique to the department.
• In depth knowledge of Federal Drug Administration (FDA) Regulations and ICH and DHHS guidelines. Ability to interact on a scientific level with medical staff, community physicians and representatives of national and pharmaceutical groups.
• Demonstrates good communication skills.

• Experience in Research required.

• Experience in Cardiology highly preferred.

Physical Requirements and Working Conditions:

• Operates all equipment necessary to perform the job. Exposed to a normal office environment.
• Position will require travel among Aurora sites and therefore there is exposure to road and weather conditions.

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.