Clinical Research Program Manager

The University of Toledo•Toledo, OH

5d•Onsite

About The Position

This role is responsible for leading the clinical trials operations team and providing oversight for clinical research coordinating staff for supported groups. The position provides expert advice to University of Toledo (UToledo) faculty and principal investigators (PIs), clinical research coordinators, leadership and other personnel involved in the execution of clinical trials throughout the lifecycle. This position maintains a working knowledge on current regulations and University policies that govern the administration of clinical research. This position will work collaboratively with the Clinical Research Information and Financial Manager to engage PIs across the institution in the growth of clinical research. This position must communicate effectively with university personnel and administrative departments as well as external sponsors and contract research organizations. This position provides training on policies, and procedures as needed.

Requirements

Bachelor’s degree in nursing, public health, healthcare management, business management or a related discipline.
Minimum of five (5) years of professional and functionally relevant experience.
Demonstrated experience in training of personnel.
Knowledge of academic medical center standard practices and policies, including but not limited to Medicare Coverage Analysis, Fair Market Value and Standard of Care.
Knowledge of FDA and Good Clinical Practice guidelines and regulations.
Experience with medical coding and knowledge of medical terminology.
Proficient in electronic health information systems (i.e., EPIC), Microsoft Office suite, and ability to learn and use other software systems as required by the position.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Background with federal and non-federal regulations for grant and contract management.

Nice To Haves

Demonstrated independent decision-making abilities.
Ability to work in a team environment under stressful and time-sensitive conditions.
Previous work history demonstrating strong organizational, analytical, and problem-solving skills.
Ability to manage competing priorities and meet time-sensitive deadlines.
Ability to maintain a strong customer-service oriented environment.
Must have strong verbal and written communication skills with a demonstrated ability to communicate effectively.
Must be able to work in collaboration with others at various levels both within and outside the University.
Demonstrated attention to detail with a high level of initiative.

Responsibilities

Leading the clinical trials operations team.
Providing oversight for clinical research coordinating staff for supported groups.
Providing expert advice to University of Toledo (UToledo) faculty and principal investigators (PIs), clinical research coordinators, leadership and other personnel involved in the execution of clinical trials throughout the lifecycle.
Maintaining a working knowledge on current regulations and University policies that govern the administration of clinical research.
Working collaboratively with the Clinical Research Information and Financial Manager to engage PIs across the institution in the growth of clinical research.
Communicating effectively with university personnel and administrative departments as well as external sponsors and contract research organizations.
Providing training on policies and procedures as needed.