Clinical Trials Operations Leader

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

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.