Clinical Research Program Manager

utoledo.edu; Toledo, Northern (OH, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

The University of Toledo seeks a Clinical Research Program Manager to lead the clinical trials operations team and oversee coordinating staff across groups. You will provide expert guidance to faculty, principal investigators, and staff throughout the life cycle of clinical trials.

Maintain up-to-date knowledge of applicable regulations and university policies, and collaborate with the Clinical Research Information and Financial Manager to engage PIs across the institution.

Qualifications

• Bachelor’s degree in nursing, public health, healthcare 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 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.

Responsibilities

• Lead the clinical trials operations team and oversee clinical research coordinating staff across groups.
• Provide expert advice to faculty, principal investigators, and staff throughout the lifecycle of clinical trials.
• Maintain knowledge of regulations and policies governing administration of clinical research.
• Collaborate with the Clinical Research Information and Financial Manager to engage PIs across the institution.

Skills

Training personnel

Regulatory knowledge (FDA & GCP)

Medical terminology

Problem solving

Grant/Contract management

Education

Bachelor's degree in nursing/public health/healthcare management or related discipline

Tools

EPIC

Microsoft Office

Healthcare software

Job description

Title: Clinical Research Program Manager

Department Org: Jacobson Clinical Research Center - 107980

Employee Classification: J1 - Salaried Full Time HSC

Bargaining Unit:Professional Staff Association

Primary Location: HSC C

Shift:1

Job Description:

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.

Minimum Qualifications:

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

Preferred Qualifications:

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.

Conditions of Employment:

To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position.

Equal Employment Opportunity Statement:

The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation.

The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect.

The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at [e-mail] or 419-530-4747 between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request.

Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.